Medical Devices
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July 2009 PMA Approvals
Below are Premarket Approvals (PMA), Product Development Protocols (PDP), Supplement and Notice Decisions. This list is generated on a monthly basis.
A PDF document that contains the "Approval letter and Summary of Safety and Effectiveness" is being added to this listing for each PMA. The PMA number will appear as a link if this document is available.
PMA Original Approvals
| APPLICATION NUMBER / DATE of APPROVAL | DEVICE TRADE NAME | COMPANY NAME CITY, STATE, & ZIP | DEVICE DESCRIPTION / INDICATIONS |
|---|---|---|---|
| P070022 7/6/09 |
Adiana Permanent Contraception System | Hologic, Inc. Marlborough, MA 01752 |
Approval for the Adiana Permanent Contraception System. The device is indicated for women who desire permanent birth control (female sterilization) by occlusion of the fallopian tubes. |
PMA Supplemental Approvals
| APPLICATION NUMBER / DATE of APPROVAL | DEVICE TRADE NAME | COMPANY NAME CITY, STATE, & ZIP | DEVICE DESCRIPTION / INDICATIONS |
|---|---|---|---|
| P810046/S230 7/15/09 Real-Time |
Voyager™ NC Coronary Dilatation Catheter | Abbott Vascular, Inc. Temecula, CA 92591 |
Approval to modify the protective balloon sheath. The device, as modified, will be marketed under the trade name Voyager™ NC Coronary Dilatation Catheter and is indicated for: 1) balloon dilation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion; 2) balloon dilation of a coronary artery occlusion for the purpose of restoring coronary flow in patients with ST-segment elevation myocardial infarction; and 3) balloon dilation of a stent after implantation. |
| P820003/S092 7/28/09 Real-Time |
CareLink Programmer and all CRT-D, CRT-P, ICDs and Pacemakers | Medtronic Cardiac Rhythm Disease Management Mounds View, MN 55112 |
Approval for version 2.2 of the Model 9986 Desktop/BOSS software for the Medtronic CareLink Programmer. |
| P850007/S028 7/10/09 Real-Time |
Physio-Stim/ Spinal-Stim Device | Orthofix, Inc. McKinney, TX 75069 |
Approval for the relocation and change of the charge management controller and the replacement of the charger unit. The device, as modified, will be marketed under the trade name Physio-Stim and Spinal-Stim. The Physio-Slim is indicated for the treatment of an established nonunion acquired secondary to trauma, excluding vertebrae and all flat bones, where the width of the nonunion defects is less than one-half the width of the bone to be treated. A nonunion is considered lo be established when the fracture site shows no visibly progressive signs of healing. The Spinal-Slim is indicated as a spinal fusion adjunct to increase the probability of fusion success and as a non-operative treatment for salvage of failed spinal fusion, where a minimum of nine months has elapsed since last surgery. |
| P850051/S071 7/28/09 Real-Time |
CareLink Programmer and all CRT-D, CRT-P, ICDs and Pacemakers | Medtronic Cardiac Rhythm Disease Management Mounds View, MN 55112 |
Approval for version 2.2 of the Model 9986 Desktop/BOSS software for the Medtronic CareLink Programmer. |
| P860057/S056 7/9/09 180-Day |
Carpentier-Edwards® PERIMOUNT® Magna Mitral Ease Pericardial Bioprosthesis | Edwards Lifesciences LLC Irvine, CA 92614 |
Approval for a new device trade name and model number to add to the Carpentier-Edwards PERIMOUNT pericardial bioprosthesis family. Model 7200TFX is identical to the previously approved Model 7000TFX with the exception of a different sizing convention. There are no changes to the dimensions of the device or the indications for use. The device as modified, will be marketed under the trade name Carpentier-Edwards® PERIMOUNT® Magna Mitral Ease Pericardial Bioprosthesis Model 7200TFX and is indicated for the replacement of malfunctioning native or prosthetic mitral valves. |
| P880003/S096 7/2/09 135-Day |
DURA STAR™ Rx PTCA Balloon Dilatation Catheter | Cordis Corporation Bridgewater, NJ 08807 |
Approval for the addition of an alternate manufacturing site for the NC Ninja balloon component. |
| P880086/S174 7/15/09 180-Day |
Accent / Accent RF Implantable Pulse Generators and Anthem / Anthem RF CRT-Ps | St. Jude Medical Sunnyvale, CA 94086 |
Approval for the Accent / Accent RF Implantable Pulse Generators and Anthem / Anthem RF CRT-Ps. The device, as modified, will be marketed under the trade name Accent / Accent RF Implantable Pulse Generators and Anthem / Anthem RF CRT-Ps. The device is indicated for: 1) Maintaining synchrony of the left and right ventricles in patients who have undergone an AV nodal ablation for chronic atrial fibrillation and have NYHA Class II or III heart failure. 2) The reduction of the symptoms of moderate to severe heart failure (NYHA Class III or IV) in those patients who remain symptomatic despite stable, optimal medical therapy, and have a left ventricular ejection fraction <=35% and a prolonged QRS duration. Implantation of Accent, Accent RF, Anthem and Anthem RF devices is indicated in one or more of the following permanent conditions: a) Syncope b) Presyncope c) Fatigue d) Disorientation due to arrhythmia/ bradycardia e) Or combination of those symptoms. Rate-Modulated Pacing is indicated for patients with chronotropic incompetence, and for those who would benefit from increased stimulation rates concurrent with physical activity. Dual-Chamber Pacing (Accent Model PM2110, Accent RF Model PM2210, Anthem and Anthem RF devices only) is indicated for those patients exhibiting: a) Sick sinus syndrome; b) Chronic, symptomatic second- and third-degree AV block; c) Recurrent Adams-Stokes syndrome; d) Symptomatic bilateral bundle branch block when tachyarrhythmia and other causes have been ruled out. Atrial Pacing is indicated for patients with sinus node dysfunction and normal AV and intraventricular conduction systems. Ventricular Pacing is indicated for patients with significant bradycardia and: a) Normal sinus rhythm with only rare episodes of A-V block or sinus arrest; b) Chronic atrial fibrillation; c) Severe physical disability. AF Suppression (Accent Model PM2110, Accent RF Model PM2210, Anthem and Anthem RF devices only) is indicated for suppression of paroxysmal or persistent atrial fibrillation episodes in patients with one or more of the above pacing indications. |
| P890003/S172 7/28/09 Real-Time |
CareLink Programmer and all CRT-D, CRT-P, ICDs and Pacemakers | Medtronic Cardiac Rhythm Disease Management Mounds View, MN 55112 |
Approval for version 2.2 of the Model 9986 Desktop/BOSS software for the Medtronic CareLink Programmer. |
| P900061/S084 7/28/09 Real-Time |
CareLink Programmer and all CRT-D, CRT-P, ICDs and Pacemakers | Medtronic Cardiac Rhythm Disease Management Mounds View, MN 55112 |
Approval for version 2.2 of the Model 9986 Desktop/BOSS software for the Medtronic CareLink Programmer. |
| P910001/S032 7/29/09 Real-Time |
CVX-300 Excimer Laser Coronary Atherectomy (ELCA) System | Spectranetics Corporation Colorado Springs, CO 80921 |
Approval for a change in the material of the proximal coupler component of the ELCA catheters. |
| P910077/S094 7/21/09 Real-Time |
Latitude Patient Management System Server Software | Boston Scientific CRM St. Paul, MN 55112 |
Approval of a software maintenance release (SMR) for the Latitude System Server Software, v5.0.6, Model 6488. |
| P920047/S031 7/8/09 180-Day |
EP Tech Cardiac Ablation System | Boston Scientific Electrophysiology San Jose, CA 95134 |
Approval for a manufacturing site located at Stellartech Research Corporation, Sunnyvale, California. |
| P930014/S025 7/16/09 135-Day |
AcrySof® UV Absorbing IOLs | Alcon Research, Ltd. Fort Worth, TX 76134 |
Approval for changes and improvements to the 8-Cavity wafer molding machine. |
| P930022/S010 7/28/09 Real-Time |
CareLink Programmer and all CRT-D, CRT-P, ICDs and Pacemakers | Medtronic Cardiac Rhythm Disease Management Mounds View, MN 55112 |
Approval for version 2.2 of the Model 9986 Desktop/BOSS software for the Medtronic CareLink Programmer. |
| P950009/S009 7/24/09 Real-Time |
BD FocalPoint™ System | BD Diagnostics Durham, NC 27703 |
Approval for design changes to the Image, Capture and Focus (ICF) circuit board in the BD FocalPoint™ Profiler. |
| P950022/S060 7/10/09 Real-Time |
Durata Leads | St. Jude Medical, CRMD Sylmar, CA 91342 |
Approval for passive fixation Durata leads with SJ4 four-pole proximal connectors; model numbers 7170Q and 7171Q. |
| P950029/S046 7/15/09 Special |
Reply SR/DR Pacemakers | ELA Medical, Inc. / Sorin Group Plymouth, MN 55441 |
Approval for the addition of an inspection step to check for excessive silicone adhesive in the set screw cavity. |
| P960040/S177 7/30/09 135-Day |
Confient and Vitality | Guidant Corporation St. Paul, MN 55112 |
Approval for the removal of a pre-screening inspection. |
| P960040/S197 7/7/09 Real-Time |
TELIGEN Family of Pulse Generators | Boston Scientific St. Paul, MN 55112 |
Approval to change the thermoformed battery stack insulator material from polyimide to PEEK. |
| P960042/S014 7/28/09 Real-Time |
Spectranetics Laser Sheath (SLS) Catheters | Spectranetics Corporation Colorado Springs, CO 80921 |
Approval for a change of material used to make the proximal coupler of the catheter. The material will be changed from Dow Magnum 9555 to Sabic Cycolac MG47MD. |
| P960043/S065 7/9/09 180-Day |
Suture Mediated Closure Systems and Accessories | Abbott Vascular, Inc. Redwood City, CA 94063 |
Approval for a manufacturing site located at Sterigenics US, Inc., Santa Teresa, New Mexico for ethylene oxide sterilization. |
| D970003/S103 7/30/09 135-Day |
Insignia, Altrua and Nexus | Guidant Corporation St. Paul, MN 55112 |
Approval for the removal of a pre-screening inspection. |
| P970003/S104 7/23/09 180-Day |
VNS Therapy System | Cyberonics, Inc. Houston, TX 77058 |
Approval of the post-approval study protocol. |
| P970012/S056 7/28/09 Real-Time |
CareLink Programmer and all CRT-D, CRT-P, ICDs and Pacemakers | Medtronic Cardiac Rhythm Disease Management Mounds View, MN 55112 |
Approval for version 2.2 of the Model 9986 Desktop/BOSS software for the Medtronic CareLink Programmer. |
| P970018/S015 7/24/09 Real-Time |
PrepStain™ System | BD Diagnostic Systems Durham, NC 27703 |
Approval for the changes made to the PrepStain software program in response to recall Z-1090-2009. |
| P970027/S007 7/8/09 Real-Time |
Abbott AxSYM Anti-HCV Assay | Abbott Diagnostics Division Abbott Park, IL 60064 |
Approval for a change in the antimicrobial formulation to the AxSYM Anti-HCV reagent SDB2 (specimen diluent). In addition, due to the reformulation of the SDB2, the instruction to use sterile water for tubing decontamination is no longer a required procedure and can be removed from the package insert labeling. |
| P980016/S197 7/28/09 Real-Time |
CareLink Programmer and all CRT-D, CRT-P, ICDs and Pacemakers | Medtronic Cardiac Rhythm Disease Management Mounds View, MN 55112 |
Approval for version 2.2 of the Model 9986 Desktop/BOSS software for the Medtronic CareLink Programmer. |
| P980035/S138 7/28/09 Real-Time |
CareLink Programmer and all CRT-D, CRT-P, ICDs and Pacemakers | Medtronic Cardiac Rhythm Disease Management Mounds View, MN 55112 |
Approval for version 2.2 of the Model 9986 Desktop/BOSS software for the Medtronic CareLink Programmer. |
| P980037/S031 7/9/09 Real-Time |
AngioJet® Rheolytic™ Thrombectomy System | MEDRAD Interventional/ Possis Minneapolis, MN 55433 |
Approval for changes to the AngioJet Ultra Thrombectomy Set packaging, and for changes to the waste bag and spike line tubing components of the AngioJet Ultra Thrombectomy Set. |
| P980044/S007 7/7/09 135-Day |
SUPARTZ® | Seikagaku Corporation Motonari Udagawa, Japan |
Approval for the following changes to the manufacturing process: 1) Replacement of WFI manufacturing equipment; 2) Addition of a sensor for preventing double capping; 3) Replacement of the multiplexer processor; 4) Addition of a syringe label sensor; 5) Replacement of the electronic balance; 6) Change of knockers used to push rubber pistons into glass syringes during the Filling Media Fill Test (MFT); 7) Addition of a second filtration tank in order to facilitate the manufacturing of plastic and glass syringe products on consecutive days; and 8) Installation of a new storage room for raw material. The device, as modified, will be marketed under the trade name SUPARTZ® and is indicated for the treatment of pain in osteoarthritis of the knee in patients who have failed to respond adequately to conservative nonpharmacologic therapy and simple analgesics, e.g., acetaminophen. |
| P980044/S009 7/8/09 180-Day |
Supartz Joint Fluid Therapy | Seikagaku Corporation Motonari Udagawa, Japan |
Approval for a distribution site change from one address in Memphis, Tennessee to another address in Memphis, Tennessee. |
| P980049/S049 7/15/09 Special |
Isoline 2CR Defibrillation Leads | ELA Medical, Inc. / Sorin Group Plymouth, MN 55441 |
Approval for the addition of two warnings regarding the use of straight stylets during implant procedures with the Isoline 2CR defibrillation leads. |
| P980050/S042 7/28/09 Real-Time |
CareLink Programmer and all CRT-D, CRT-P, ICDs and Pacemakers | Medtronic Cardiac Rhythm Disease Management Mounds View, MN 55112 |
Approval for version 2.2 of the Model 9986 Desktop/BOSS software for the Medtronic CareLink Programmer. |
| P990001/S055 7/28/09 Real-Time |
CareLink Programmer and all CRT-D, CRT-P, ICDs and Pacemakers | Medtronic Cardiac Rhythm Disease Management Mounds View, MN 55112 |
Approval for version 2.2 of the Model 9986 Desktop/BOSS software for the Medtronic CareLink Programmer. |
| P990066/S033 7/10/09 Real-Time |
GE-Healthcare Senographe Digital Mammography System | GE Healthcare Milwaukee, WI 53201 |
Approval for a modification to the Senographe DS and Senographe Essential FFDM systems that will remove both Magnification Stands and corresponding magnification compression paddles for both systems. The components that are proposed for removal from the configuration will still be available to the customer as optional equipment. |
| P000053/S024 7/6/09 Real-Time |
AMS 800® Urinary Control System, 3.5 cm Cuff |
American Medical Systems, Inc. Minnetonka, MN 55343 |
Approval of a new, smaller 3.5 cm cuff size to be used as a component of the existing AMS 800® Urinary Control System, and for related labeling changes. |
| P010012/S183 7/30/09 180-Day |
Programmer Software Application Model 2845 version 4.34 for the Contak Renewal, Contak Renewal 3, Contak Renewal 3 HE, Contak Renewal 3 RF, and Contak Renewal 3 RF HE |
Boston Scientific St. Paul, MN 55112 |
Approval for the Programmer Software Application Model 2845 version 4.34 for the Contak Renewal (Model H135), Contak Renewal 3 (Models H170, H175), Contak Renewal 3 HE (Models H177, H179), Contak Renewal 3 RF (Models H210, H215, H250, H255), and Contak Renewal 3 RF HE (Models H217, H219, H257, H259). |
| P010012/S192 7/30/09 135-Day |
Renewal and Livian | Guidant Corporation St. Paul, MN 55112 |
Approval for the removal of a pre-screening inspection. |
| P010012/S211 7/7/09 Real-Time |
COGNIS Family of Pulse Generators | Boston Scientific St. Paul, MN 55112 |
Approval to change the thermoformed battery stack insulator material. |
| P010013/S024 7/31/09 Special |
NovaSure® Impedance Controlled Endometrial Ablation System | Hologic, Inc. Marlborough, MA 01752 |
Approval for changes intended to improve the Instructions For Use by adding a contraindication for use in patients with a metal object in the uterus or uterine cavity. |
| P010015/S070 7/28/09 Real-Time |
CareLink Programmer and all CRT-D, CRT-P, ICDs and Pacemakers | Medtronic Cardiac Rhythm Disease Management Mounds View, MN 55112 |
Approval for version 2.2 of the Model 9986 Desktop/BOSS software for the Medtronic CareLink Programmer. |
| P010021/S016 7/15/09 180-Day |
VITROS Immunodiagnostic Products Anti-HCV Reagent Pack and VITROS Immunodiagnostic Products Anti-HCV Calibrator |
Ortho-Clinical Diagnostic, Inc. Rochester, NY 14626 |
Approval for revision of the Intended Use to include use of the VITROS 5600 Integrated System and VITROS 3600 Immunodiagnostic System with the Anti-HCV Assay. The device, as modified, will be marketed under the trade name VITROS Immunodiagnostic Products Anti-HCV Reagent Pack, VITROS Immunodiagnostic Products Anti-HCV Calibrator and is indicated for: VITROS Immunodiagnostic Products Anti-HCV Reagent Pack: For the in vitro qualitative detection of immunoglobulin G antibody to hepatitis C virus (anti-HCV) in human serum and plasma (heparin, EDTA and sodium citrate) using the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System. Three recombinant hepatitis C virus encoded antigens are used. Assay results, in conjunction with other laboratory results and clinical information, may be used to provide presumptive evidence of infection with hepatitis C virus, (state or associated disease not determined), in persons with signs or symptoms of hepatitis and in persons at risk for hepatitis C infection. In addition, this assay may be used to screen for hepatitis C infection in pregnant women to identify neonates who are at high risk of acquiring HCV during the prenatal period. VITROS Immunodiagnostic Products Anti-HCV Calibrator: For use in the calibration of the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System for the in vitro qualitative detection of immunoglobulin G antibody to hepatitis C virus (anti-HCV) in human serum and plasma (heparin, EDTA and sodium citrate) using VITROS Anti-HCV Reagent Packs. The VITROS Anti-HCV Calibrator has been validated for use only on the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System with the VITROS Immunodiagnostic Products Anti-HCV Reagent Pack. |
| P010029/S007 7/1/09 135-Day |
Euflexxa® 1% Sodium Hyaluronate | Ferring Pharmaceuticals, Inc. Parsippany, NJ 07054 |
Approval for the sterile sodium hyaluronate ( NaHA) to be stored in sterile, disposable polyethylene bags for up to 48 hours prior to filling the syringes. The device, as modified, will be marketed under the trade name Euflexxa® and is indicated for the treatment of pain in osteoarthritis of the knee in patients who have failed to respond adequately to conservative nonpharmacologic therapy and simple analgesics, e.g., acetaminophen. |
| P010031/S158 7/28/09 Real-Time |
CareLink Programmer and all CRT-D, CRT-P, ICDs and Pacemakers | Medtronic Cardiac Rhythm Disease Management Mounds View, MN 55112 |
Approval for version 2.2 of the Model 9986 Desktop/BOSS software for the Medtronic CareLink Programmer. |
| P010032/S031 7/31/09 180-Day |
Genesis, GenesisXP/ Dual XP, GenesisRC, Genesis Dual 4-Channel, Eon, EonC, and EonMini Neurostimulation (IPG) Systems |
Advanced Neuromodulation Systems Plano, TX 75024 |
Approval for the Rapid Programmer software version 3.3.0. |
| P020014/S026 7/16/09 180-Day |
Conceptus Essure® System for Permanent Birth Control | Conceptus, Inc. Mountain View, CA 94041 |
Approval for a manufacturing site located at AvailMed S.A. de C.V., Tijuana, Mexico. |
| P020018/S033 7/24/09 Real-Time |
Zenith AAA Endovascular Graft | Cook, Inc. Bloomington, IN 47402 |
Approval for labeling changes including a change to conditional MR compatibility. |
| P020025/S015 7/8/09 180-Day |
EP Tech EPT-1000XP RF Ablation System | Boston Scientific Electrophysiology San Jose, CA 95134 |
Approval for a manufacturing site located at Stellartech Research Corporation, Sunnyvale, California. |
| P020026/S061 7/23/09 135-Day |
CYPHER® Sirolimus-Eluting Coronary Stent on RAPTOR™ Over-the-Wire Delivery System or RAPTORRAIL® Rapid Exchange Delivery System | Cordis Corporation Miami Lakes, FL 33014 |
Approval for an alternate quality control test method. |
| P020045/S026 7/7/09 180-Day |
7F Freezor Cardiac CryoAblation Catheter and Cryoconsole, 7F Freezor Xtra Surgical Catheter and Cryoconsole, and 9F Freezor MAX Surgical Catheter and Cryoconsole | Applied Physics Galisteo, NM 87540 |
Approval for a new CryoAblation console which includes changes to the hardware, software, user interface, and mechanical circuit for the 7F Freezor Cardiac CryoAblation Catheter and Cryoconsole, 7F Freezor Xtra Surgical Catheter and Cryoconsole, and 9F Freezor MAX Surgical Catheter and Cryoconsole. The new CryoAblation console device, as modified, will be marketed under the trade name Cryoconsole to be used with the aforementioned catheters. |
| P030017/S030 7/22/09 180-Day |
Precision® Spinal Cord Stimulation (SCS) System | Boston Scientific Neuromodulation Corporation Sylmar, CA 91342 |
Approval for a manufacturing site located at Boston Scientific Neuromodulation Corporation in Valencia, California. |
| P030026/S016 7/15/09 180-Day |
VITROS Immunodiagnostic Products Anti-HBc IgM Reagent Pack and VITROS Immunodiagnostic Products Anti-HBc Calibrator | Ortho-Clinical Diagnostic, Inc. Rochester, NY 14626 |
Approval for revision of the Intended Use to include use of the VITROS 5600 Integrated System and VITROS 3600 Immunodiagnostic System with the Anti-HBc IgM Assay. The device, as modified, will be marketed under the trade name VITROS Immunodiagnostic Products Anti-HBc IgM Reagent Pack, VITROS Immunodiagnostic Products Anti-HBc Calibrator and is indicated for: VITROS Immunodiagnostic Products Anti-HBc IgM Reagent Pack: For the in vitro qualitative detection of IgM antibody to hepatitis B core antigen (anti-HBc IgM) in human adult and pediatric serum and plasma (heparin, EDTA and citrate) and neonate serum using the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System. Assay results, in conjunction with other serological and clinical information, may be used for the laboratory diagnosis of individuals with acute or chronic hepatitis B. VITROS Immunodiagnostic Products Anti-HBc IgM Calibrator: For use in the calibration of the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System when used for the in vitro qualitative detection of IgM antibody to hepatitis B virus core antigen (anti-HBc IgM) in human adult and pediatric serum and plasma (EDTA, heparin or citrate) and neonate serum using VITROS Anti-HBc IgM Reagent Packs. The VITROS Anti-HBc IgM Calibrator has been validated for use only on the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System with the VITROS Immunodiagnostic Products Anti-HBc IgM Reagent Packs. |
| P030029/S003 7/31/09 180-Day |
ADVIA Centaur Anti-HBs ReadyPack Reagents on the Centaur CP Analyzer, ADVIA Centaur Anti-HBs Quality Controls on the Centaur CP Analyzer | Siemens Healthcare Diagnostics Tarrytown, NY 10591 |
Approval for the transition of the ADVIA Centaur Anti-HBs assay to a new platform in the Centaur family of instruments, the Centaur CP. ADVIA Centaur Anti-HBs ReadyPack Reagents on the Centaur CP Analyzer The ADVIA Centaur Anti-HBs assay is an in vitro diagnostic immunoassay for the qualitative determination of total antibodies to hepatitis B surface antigen in human serum or plasma (EDTA or heparinized) using the ADVIA Centaur CP System. The assay results may be used as an aid in the determination of susceptibility to hepatitis B virus (HBV) infection in individuals prior to or following HBV vaccination or where vaccination status is unknown. Assay results may be used with other HBV serological markers for the laboratory diagnosis of HBV disease associated with HBV infection. A reactive assay result will allow a differential diagnosis in individuals displaying signs and symptoms of hepatitis in whom etiology is unknown. ADVIA Centaur Anti-HBs Quality Controls on the Centaur CP Analyzer The ADVIA Centaur Anti-HBs Quality Controls are intended for in vitro diagnostic use in monitoring the performance of the Anti-HBs assay on the ADVIA Centaur Systems. The performance of the ADVIA Centaur Anti-HBs quality controls has not been established with any other anti-HBs assay. |
| P030034/S002 7/10/09 Real-Time |
Cervical-Stim Cervical Fusion System | Orthofix, Inc. McKinney, TX 75069 |
Approval for the relocation and change of the charge management controller and the replacement of the charger unit. The device, as modified, will be marketed under the trade name Cervical-Stim Cervical Fusion System and is indicated as an adjunct to cervical fusion surgery in patients at high risk for non-fusion. |
| P030035/S053 7/15/09 180-Day |
Accent / Accent RF Implantable Pulse Generators and Anthem / Anthem RF CRT-Ps | St. Jude Medical Sunnyvale, CA 94086 |
Approval for the Accent / Accent RF Implantable Pulse Generators and Anthem / Anthem RF CRT-Ps. The device, as modified, will be marketed under the trade name Accent / Accent RF Implantable Pulse Generators and Anthem / Anthem RF CRT-Ps. The device is indicated for: 1) Maintaining synchrony of the left and right ventricles in patients who have undergone an AV nodal ablation for chronic atrial fibrillation and have NYHA Class II or III heart failure; 2) The reduction of the symptoms of moderate to severe heart failure (NYHA Class III or IV) in those patients who remain symptomatic despite stable, optimal medical therapy, and have a left ventricular ejection fraction ≤35% and a prolonged QRS duration. Implantation of Accent, Accent RF, Anthem and Anthem RF devices is indicated in one or more of the following permanent conditions: a) Syncope; b) Presyncope; c) Fatigue; d) Disorientation due to arrhythmia/ bradycardia; e) Or combination of those symptoms. Rate-Modulated Pacing is indicated for patients with chronotropic incompetence, and for those who would benefit from increased stimulation rates concurrent with physical activity. Dual-Chamber Pacing (Accent Model PM2110, Accent RF Model PM2210, Anthem and Anthem RF devices only) is indicated for those patients exhibiting: a) Sick sinus syndrome b) Chronic, symptomatic second- and third-degree AV block; c) Recurrent Adams-Stokes syndrome; d) Symptomatic bilateral bundle branch block when tachyarrhythmia and other causes have been ruled out. Atrial Pacing is indicated for patients with sinus node dysfunction and normal AV and intraventricular conduction systems. Ventricular Pacing is indicated for patients with significant bradycardia and: a) Normal sinus rhythm with only rare episodes of A-V block or sinus arrest; b) Chronic atrial fibrillation c) Severe physical disability. AF Suppression (Accent Model PM2110, Accent RF Model PM2210, Anthem and Anthem RF devices only) is indicated for suppression of paroxysmal or persistent atrial fibrillation episodes in patients with one or more of the above pacing indications. |
| P030050/S002 7/28/09 Panel |
Sculptra Aesthetic | Sanofi Aventis U.S. LLC Malvern, PA 19355 |
Approval for Sculptra Aesthetic. The device is indicated for use in immune-competent people as a single regimen for correction of shallow to deep nasolabial fold contour deficiencies and other facial wrinkles in which deep dermal grid pattern (cross-hatch) injection technique is appropriate. |
| P040038/S015 7/23/09 180-Day |
Xact® Carotid Stent System | Abbott Vascular, Inc. Santa Clara, CA 95054 |
Approval for modifications to the labeling to include the post-approval study findings. |
| P040044/S015 7/13/09 Special |
Mynx Vascular Closure Device | Access Closure, Inc. Mountain View, CA 94043 |
Approval for changes to the Instructions for Use. Specifically, to include a 10 second and 60 second wait time for diagnostic and interventional procedures respectively, prior to deflating and removing the balloon catheter. |
| P050006/S012 7/27/09 135-Day |
Gore Helex Septal Occluder | W.L. Gore & Associates, Inc. Flagstaff, AZ 86001 |
Approval for a duplicate manufacturing site for the final assembly step of the device. |
| P050007/S014 7/9/09 180-Day |
Vascular Closure Systems | Abbott Vascular, Inc. Redwood City, CA 94063 |
Approval for a manufacturing site located at Sterigenics US, Inc., Santa Teresa, New Mexico for ethylene oxide sterilization. |
| P050017/S004 7/23/09 180-Day |
Zilver® Vascular Stent with Rapid Exchange Delivery System | Cook, Inc. Bloomington, IN 47402 |
Approval for a modification from the existing over-the-wire delivery system to a rapid exchange delivery system for the device. The device, as modified, will be marketed under the trade name Zilver® Vascular Stent with Rapid Exchange Delivery System and is indicated for use as an adjunct to percutaneous transluminal angioplasty (PTA) in the treatment of symptomatic vascular disease of the iliac arteries up to 100 mm in length, with a reference vessel diameter of 5 to 9 mm. Patients must be suitable for PTA and stent treatment. |
| P050043/S002 7/24/09 Real-Time |
7F FISH-SP™ Device | Morris Innovative Research, Inc. Bloomington, IN 47403 |
Approval for the addition of the 7F FISH-SP™ device to the FISH product line. The device, as modified, will be marketed under the trade name 7F FISH-SP™ device for closure and is indicated for percutaneous access and closure of the common femoral artery while reducing time to hemostasis, ambulation and time to eligible discharge in patients requiring access of 7F for endovascular procedure with sheath removal. |
| P050047/S007 7/7/09 135-Day |
Juvederm Hyaluronate Gel Implant | Allergan, Inc. Goleta, CA 93117 |
Approval for a change in the release of product. |
| P050051/S004 7/23/09 180-Day |
ARCHITECT AUSAB Reagent Kit on ARCHITECT i 1000 SR, ARCHITECT AUSAB Calibrators on ARCHITECT i 1000 SR and ARCHITECT AUSAB Controls on ARCHITECT i 1000 SR | Abbott Laboratories Diagnostic Division Abbott Park, IL 60064 |
Approval to extend the application of the ARCHITECT AUSAB assay, currently approved for use on the Abbott ARCHITECT i2000/ i 2000 SR, onto a new ARCHITECT i system family member, the ARCHITECT i 1000 SR. ARCHITECT AUSAB Reagent Kit on ARCHITECT i1000 SR: The ARCHITECT AUSAB assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of antibody to hepatitis B surface antigen (anti-HBs) in human adult and pediatric serum and plasma (dipotassium EDTA, lithium heparin, and sodium heparin) and neonatal serum. It is intended for quantitative measurement of antibody response following hepatitis B virus (HBV) vaccination, determination of HBV immune status, and for the laboratory diagnosis of HBV disease associated with HBV infection when used in conjunction with other laboratory results and clinical information. ARCHITECT AUSAB Calibrators on ARCHITECT i1000 SR: The ARCHITECT AUSAB Calibrators are used to calibrate the ARCHITECT i System when the system is used for the quantitative determination of antibody to hepatitis B surface antigen (anti-HBs) using the ARCHITECT AUSAB Reagent Kit. The performance of the ARCHITECT AUSAB Calibrators has not been established with any other anti-HBs assay. ARCHITECT AUSAB Controls on ARCHITECT i1000 SR: The ARCHITECT AUSAB Controls are used for monitoring the performance of the ARCHITECT i System when used for the quantitative determination of antibody to hepatitis B surface antigen (anti-HBs) using the ARCHITECT AUSAB Reagent Kit. The performance of the ARCHITECT AUSAB Controls has not been established with any other anti-HBs assay. |
| P050052/S019 7/13/09 180-Day |
Radiesse | BioForm Medical Franksville, WI 53126 |
Approval for modifications to the instructions for use to provide detailed instructions for mixing Radiesse with 2% lidocaine HCl (resulting in a final concentration of 0.3% lidocaine) prior to injection for the indicated use of subdermal implantation for the correction of moderate to severe facial wrinkles and folds, such as nasolabial folds. The mixing of Radiesse and lidocaine is to be accomplished using a mixing kit that will be made available separate from the Radiesse device. |
| P060007/S002 7/13/09 180-Day |
ARCHITECT HBsAg Reagent Kit, ARCHITECT HBsAg Calibrators, ARCHITECT HBsAg controls, ARCHITECT HBsAg Confirmatory Reagent Kit and ARCHITECT HBsAg Confirmatory Manual Diluent | Abbott Laboratories Diagnostics Division Abbott Park, IL 60064 |
Approval to extend the application of the ARCHITECT HBsAg/ ARCHITECT HBsAg Confirmatory assay, currently approved for use on the Abbott ARCHITECT i2000/i2000SR, onto a new ARCHITECT i system family member, the ARCHITECT i 1000SR. |
| P060008/S011 7/13/09 Panel |
TAXUS® Liberté® Long Paclitaxel-Eluting Coronary Stent System (Monorail and Over-the-Wire Delivery Systems) | Boston Scientific Corporation Maple Grove, MN 55311 |
Approval to expand the product matrix to include the 38 mm length TAXUS® Liberté® Paclitaxel-Eluting Coronary Stent System. The device size will be marketed under the trade name TAXUS® Liberté® Long Paclitaxel-Eluting Coronary Stent System (Monorail and Over-the-Wire Delivery Systems), and is indicated for improving luminal diameter for the treatment of de novo lesions in native coronary arteries >=2.75 mm to <=4.00 mm in diameter in lesions <=34 mm in length. |
| P060017/S003 7/9/09 180-Day |
GeneSearch™ Breast Lymph Node (BLN) Assay | Veridex, LLC Raritan, NJ 08869 |
Approval for: 1) a manufacturing site located at Veridex, LLC in Warren, New Jersey; 2) the addition of a second existing site; and 3) a change in raw material specifications. |
| P060033/S031 7/13/09 180-Day |
Endeavor and Endeavor Sprint Zotarolimus-Eluting Coronary Stent Systems | Medtronic Vascular Santa Rosa, CA 95403 |
Approval for changes to the patient guide. |
| P070014/S001 7/30/09 Real-Time |
LifeStent and LifeStent XL Vascular Stent Systems | Bard Peripheral Vascular, Inc. Tempe, AZ 85280 |
Approval to modify the name and package label for the LifeStent Vascular Stent Systems. Specifically, the word "FlexStar" will be removed from the trade name and "& Biliary" will be added to the device package labels to reflect the cleared biliary indication for this device. The device, as modified, will be marketed under the trade name LifeStent Vascular Stent System and LifeStent XL Vascular Stent System and is indicated for improvement of luminal diameter in the treatment of de-novo or restenotic lesion in the native SFA and proximal popliteal arteries. |
| P070015/S017 7/9/09 135-Day |
XIENCE V™ and PROMUS™ Everolimus Eluting Coronary Stent Systems (EECSS) | Abbott Vascular Temecula, CA 92590 |
Approval for the addition of several test methods for an excipient used in the manufacture of the device. |
| P080004/S002 7/23/09 135-Day |
Intraocular Lens | Hoya Surgical Optics, Inc. Chino Hills, CA 91709 |
Approval for a change in the contracted Limulus Amebocyte Lysate (LAL) test laboratory. |
30-Day Notices (135 Day Supplement was not required)
| APPLICATION NUMBER / DATE of APPROVAL | DEVICE TRADE NAME | COMPANY NAME CITY, STATE, & ZIP | DEVICE DESCRIPTION / INDICATIONS |
| N16837/S007 7/21/09 |
Artegraft Collagen Vascular Graft | Artegraft, Inc. North Brunswick, NJ 08902 |
Modification to the Quality Control Sampling Plan for a portion of finished device testing. |
| P790007/S022 7/27/09 |
Hancock® I Low Porosity and Modified Orifice Valved Conduit | Medtronic, Inc. Santa Ana, CA 92705 |
Addition of an alternate supplier. |
| P790018/S052 7/9/09 |
Medtronic Hall™ Rotatable Aortic Valve Collagen Impregnated Conduit | Medtronic, Inc. Mounds View, MN 55112 |
Changes to the bioburden testing and change to the sterilization test methods. |
| P810032/S054 7/23/09 |
PMMA Multi-Piece Posterior Chamber Intraocular Lenses | Alcon Research, Ltd. Fort Worth, TX 76134 |
Use of an alternate ethylene oxide gas blend sterilant used during terminal sterilization. |
| P840001/S139 7/10/09 |
Spinal Cord Stimulation Family of Neurostimulation Leads | Medtronic Neurostimulation Minneapolis, MN 55432 |
Change to the duration of the drying time for the adhesive used in the bonding application of neurostimulation leads. |
| P840039/S058 7/31/09 |
Polymethylmetha-crylate Intraocular Lenses | Bausch & Lomb, Inc. Rochester, NY 14609 |
Change in the blow-off process in the air drying of the polymethylmethacrylate lenses. |
| P840060/S031 7/23/09 |
PMMA Single-Piece Posterior Chamber Intraocular Lenses | Alcon Research, Ltd. Fort Worth, TX 76134 |
Use of an alternate ethylene oxide gas blend sterilant used during terminal sterilization. |
| P860057/S058 7/21/09 |
Carpentier- Edwards Perimount Pericardial Bioprosthesis |
Edwards Lifesciences LLC Irvine, CA 92614 |
New Flow and Leaflet Coaptation testing system. |
| P870056/S033 7/9/09 |
Carpentier-Edwards Bioprosthetic Pulmonic Valved Conduit | Edwards Lifesciences LLC Irvine, CA 92614 |
Additional supplier of yarn material. |
| P870056/S034 7/23/09 |
Carpentier-Edwards Bioprosthetic Valved Conduit | Edwards Lifesciences LLC Irvine, CA 92614 |
Additional supplier for polyester sewing thread. |
| P880006/S062 7/10/09 |
Regency Pacemakers | St. Jude Medical Cardiac Rhythm Management Division | Three sterilization changes. |
| P880006/S063 7/17/09 |
Sensolog/Dialog/ Regency Family of Pacemakers | St. Jude Medical Cardiac Rhythm Management Division | Alternate buffing process. |
| P880086/S176 7/10/09 |
AddVent, Affinity, Identify, Verity, Victory, Zephyr Pacemakers | St. Jude Medical Cardiac Rhythm Management Division | Three sterilization changes. |
| P880086/S177 7/17/09 |
Affinity/Integrity/ Victory Family of Pacemakers | St. Jude Medical Cardiac Rhythm Management Division | Alternate buffing process. |
| P880087/S013 7/23/09 |
PMMA Single-Piece Anterior Chamber Intraocular Lenses | Alcon Research, Ltd. Fort Worth, TX 76134 |
Use of an alternate ethylene oxide gas blend sterilant used during terminal sterilization. |
| P880090/S026 7/31/09 |
Polymethylmetha-crylate Intraocular Lenses | Bausch & Lomb, Inc. Rochester, NY 14609 |
Change in the blow-off process in the air drying of the polymethylmetha-crylate lenses. |
| P910023/S212 7/10/09 |
Cadence ICDs | St. Jude Medical Cardiac Rhythm Management Division | Three sterilization changes. |
| P910023/S213 7/17/09 |
Cadence Family of Implantable Cardioverter Defibrillators (ICDs) | St. Jude Medical Cardiac Rhythm Management Division | Alternate buffing process. |
| P910023/S214 7/23/09 |
Cadence Family of Implantable Cardioverter Defibrillators (ICDs) | St. Jude Medical Cardiac Rhythm Management Division | Change in wafer test and hybrid test. |
| P910061/S018 7/16/09 |
Soflex™ and SofPort™ Posterior Chamber Intraocular Lenses | Bausch & Lomb Rochester, NY 14609 |
Change from sterile water to processed water in final product inspection. |
| P910077/S095 7/6/09 |
Model 3120 Zoom® Latitude™ Programming System | Boston Scientific Cardiac Rhythm Management St. Paul, MN 55112 |
Addition of a new supplier for the DSUB component and specification changes to the component. |
| P930014/S035 7/23/09 |
AcrySof® Monofocal and AcrySof® Toric Posterior Chamber Intraocular Lenses and AcrySert® Delivery System | Alcon Research, Ltd. Fort Worth, TX 76134 |
Use of an alternate ethylene oxide gas blend sterilant used during terminal sterilization. |
| P950022/S061 7/2/09 |
Durata, Riata ST Optim, and Riata ST Families of Leads | St. Jude Medical, Inc. Sylmar, CA 91342 |
Addition of an alternate supplier. |
| P950022/S062 7/10/09 |
Riata, Riata ST, Durata Leads | St. Jude Medical Cardiac Rhythm Management Division | Three sterilization changes. |
| P960013/S047 7/10/09 |
Tendril, Tendril ST, OptiSense Leads | St. Jude Medical Cardiac Rhythm Management Division | Three sterilization changes. |
| P960030/S026 7/10/09 |
Passive Plus, IsoFlex P, IsoFlex Optim Leads |
St. Jude Medical Cardiac Rhythm Management Division | Three sterilization changes. |
| P960040/S201 7/10/09 |
TELIGEN Implantable Cardioverter Defibrillator | Boston Scientific Corporation St. Paul, MN 55112 |
Change to the tolerance for a component. |
| P970004/S074 7/10/09 |
InterStim® Family of Neurostimulation Leads | Medtronic Neurostimulation Minneapolis, MN 55432 |
Change to the duration of the drying time for the adhesive used in the bonding application of neurostimulation leads. |
| P970012/S055 7/10/09 |
Kappa 400 DR/SR Families of Implantable Pulse Generators (IPGs) | Medtronic, Inc. Cardiac Rhythm Disease Management Mounds View, MN 55112 |
Addition of a new sterilizer and aerator. |
| P970013/S029 7/10/09 |
Microny Pacemakers | St. Jude Medical Cardiac Rhythm Management Division | Three sterilization changes. |
| P970013/S030 7/17/09 |
Microny Family of Pacemakers | St. Jude Medical Cardiac Rhythm Management Division | Alternate buffing process. |
| P970018/S016 7/2/09 |
PrepStain™ System | Tripath Imaging, Inc. Durham, NC 27703 |
Changes to the method of manufacturing from a manual process to an automated process to reduce production costs and improve control of the manufacturing process. |
| P970031/S025 7/27/09 |
Freestyle® Aortic Root Bioprosthesis | Medtronic, Inc. Santa Ana, CA 92705 |
Addition of an alternate supplier. |
| P970051/S051 7/16/09 |
Nucleus 24 Cochlear Implant System | Cochlear Americas Centennial, CO 80111 |
Amendment to the Environmental Monitoring Program and the Microbial and Environmental Controls procedure. |
| P980016/S196 7/10/09 |
GEM II, Marquis, Maximo, Intrinsic, EnTrust, Virtuoso, Maximo II DR/VR, Virtuoso II DR/VR, and Secura DR/VR Families of Implantable Cardioverter Defibrillators (ICDs) Maximo II Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) |
Medtronic, Inc. Cardiac Rhythm Disease Management Mounds View, MN 55112 |
Addition of a new sterilizer and aerator. |
| P980016/S198 7/30/09 |
Marquis, Maximo, Intrinsic, EnTrust, Virtuoso, Maximo II, Secura, Virtuoso II Families of Implantable Cardioverter Defibrillators | Medtronic, Inc. Cardiac Rhythm Disease Management Mounds View, MN 55112 |
Change to the supplier’s manufacturing process. |
| P980022/S056 7/16/09 |
SOF-SENSOR Glucose Sensor | Medtronic MiniMed Northridge, CA 91325 |
Changes to the tube preparation and sensor fabrication processes. |
| P980035/S137 7/10/09 |
Kappa 600/700, 650, 800/900, Relia, Sigma, Medtronic 350, EnPulse, EnRhythm, AT500, Adapta/Versia/ Sensia Families of Implantable Pulse Generators (IPGs) | Medtronic, Inc. Cardiac Rhythm Disease Management Mounds View, MN 55112 |
Addition of a new sterilizer and aerator. |
| P980035/S139 7/30/09 |
EnRhythm Implantable Pulse Generator | Medtronic, Inc. Cardiac Rhythm Disease Management Mounds View, MN 55112 |
Change to the supplier’s manufacturing process. |
| P980040/S027 7/17/09 |
Tecnis 1 Piece IOL Model ZCB00 | Abbott Medical Optics, Inc. Santa Ana, CA 92705 |
Change in the sterilization process parameters for the device. |
| P980040/S028 7/23/09 |
Tecnis 1 Piece IOL Model ZCB00 | Abbott Medical Optics, Inc. Santa Ana, CA 92705 |
Change in the ethylene oxide residuals testing. |
| P980043/S020 7/27/09 |
Hancock® II Porcine Bioprosthesis | Medtronic, Inc. Santa Ana, CA 92705 |
Addition of an alternate supplier. |
| P990001/S054 7/10/09 |
Dema, C-Series, and T-Series Families of Implantable Pulse Generators (IPGs) | Medtronic, Inc. Cardiac Rhythm Disease Management Mounds View, MN 55112 |
Addition of a new sterilizer and aerator. |
| P990064/S027 7/27/09 |
Mosaic® Porcine Bioprosthesis | Medtronic, Inc. Santa Ana, CA 92705 |
Addition of an alternate supplier. |
| P000010/S014 7/30/09 |
Amplicor HCV Test, Version 2.0 | Roche Molecular Systems, Inc. Pleasanton, CA 94588 |
Elimination of functional release testing for the final bulk materials prior to filling. |
| P000012/S021 7/30/09 |
Cobas AmpliPrep/Cobas Amplicor HCV Test, Version 2.0 | Roche Molecular Systems, Inc. Pleasanton, CA 94588 |
Elimination of functional release testing for the final bulk materials prior to filling. |
| P010012/S216 7/10/09 |
COGNIS Cardiac Resynchronization HE Defibrillator | Boston Scientific Corporation St. Paul, MN 55112 |
Change to the tolerance for a component. |
| P010015/S069 7/10/09 |
InSync and InSync III Families of Cardiac Resynchronization Therapy Pacemakers (CRT-Ps) |
Medtronic, Inc. Cardiac Rhythm Disease Management Mounds View, MN 55112 |
Addition of a new sterilizer and aerator. |
| P010031/S157 7/10/09 |
InSync, InSync Marquis, InSync Marquis II, InSync Marquis III, InSync II Protect, InSync III Protect, InSync Sentry, InSync Maximo, Families of Implantable Cardioverter Defibrillators (ICDs), Concerto, Concerto II, Maximo II, and Consulta Families of Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) |
Medtronic, Inc. Cardiac Rhythm Disease Management Mounds View, MN 55112 |
Addition of a new sterilizer and aerator. |
| P010031/S159 7/30/09 |
InSync II Marquis, InSync III Marquis, InSync II Protect, InSync Sentry, InSync Maximo, Concerto, Maximo II, Consulta, and Concerto II Families of Cardiac Resynchronization Therapy Defibrillators |
Medtronic, Inc. Cardiac Rhythm Disease Management Mounds View, MN 55112 |
Change to the supplier’s manufacturing process. |
| P020004/S044 7/17/09 |
Gore Excluder® AAA Endoprosthesis | W.L. Gore & Associates, Inc. Flagstaff, AZ 86001 |
Change to expand the manufacturing capabilities to a new facility, Gore Deer Valley in Phoenix, Arizona. |
| P020004/S046 7/29/09 |
Gore Excluder® AAA Endoprosthesis | W.L. Gore & Associates, Inc. Flagstaff, AZ 86001 |
Change in the stent winding manufacturing process. |
| P020047/S015 7/28/09 |
Multi-Link Vision® Family of Coronary Stent Systems | Abbott Vascular Temecula, CA 92592 |
Changes in stent retention testing for the device. |
| P030035/S056 7/10/09 |
Frontier, Frontier II Pacemakers, and Aescula Leads | St. Jude Medical Cardiac Rhythm Management Division | Three sterilization changes. |
| P030035/S057 7/17/09 |
Frontier/Frontier II Family of Cardiac Resynchronization Therapy Pacemakers (CRT-Ps) |
St. Jude Medical Cardiac Rhythm Management Division | Alternate buffing process. |
| P030054/S127 7/10/09 |
Epic HF/Epic+, HF/Epic II, HF/Epic II+ HF, Atlas, HF/Atlas+, HF Atlas II, HF/Atlas II+ HF CRT-Ds, and Quick Site, QuickFlex Leads |
St. Jude Medical Cardiac Rhythm Management Division | Three sterilization changes. |
| P030054/S128 7/17/09 |
Epic HF/Atlas+ Family of Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) | St. Jude Medical Cardiac Rhythm Management Division | Alternate buffing process. |
| P030054/S129 7/23/09 |
Epic HF/Atlas+ Family of Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) | St. Jude Medical Cardiac Rhythm Management Division | Change in wafer test and hybrid test. |
| P040020/S019 7/23/09 |
AcrySof® Multifocal Posterior Chamber Intraocular Lenses | Alcon Research, Ltd. Fort Worth, TX 76134 |
Use of an alternate ethylene oxide gas blend sterilant used during terminal sterilization. |
| P040024/S041 7/10/09 |
Restylane® and Perlane® Injectable Gel | Medicis Pharmaceutical Corporation Scottsdale, AZ 85258 |
Changes in sanitation criteria for water for injection (WFI), reduction of water sampling for purified water (PW) and WFI, and reduction of frequency of periodic review of utility systems. |
| P040027/S015 7/10/09 |
Gore VIABAHN® TIPS Endoprosthesis | W.L. Gore & Associates, Inc. Flagstaff, AZ 86001 |
Elimination of several environmental monitoring tests. |
| P040027/S016 7/30/09 |
Gore Viatorr® TIPS Endoprosthesis | W.L. Gore & Associates, Inc. Flagstaff, AZ 86001 |
Relocation of the manufacturing of the device from one building to another within the same campus. |
| P040037/S020 7/8/09 |
Gore VIABAHN® Endoprosthesis | W.L. Gore & Associates, Inc. Flagstaff, AZ 86001 |
Addition of an alternate manufacturing location within the Flagstaff, Arizona facility. |
| P040037/S021 7/10/09 |
Gore VIABAHN® Endoprosthesis | W.L. Gore & Associates, Inc. Flagstaff, AZ 86001 |
Elimination of several environmental monitoring tests. |
| P040043/S030 7/29/09 |
Gore TAG® Thoracic Endoprosthesis | W.L. Gore & Associates, Inc. Flagstaff, AZ 86001 |
Change in the stent winding manufacturing process. |
| P050007/S016 7/27/09 |
StarClose SE® Vascular Closure System | Abbott Vascular, Inc. Redwood City, CA 94063 |
Addition of an alternate supplier. |
| P050028/S005 7/30/09 |
Cobas TaqMan HBV Test for use with The High Pure System | Roche Molecular Systems, Inc. Pleasanton, CA 94588 |
Elimination of functional release testing for the final bulk materials prior to filling. |
| P050044/S009 7/23/09 |
Vitagel Surgical Hemostat | Orthovita, Inc. Malvern, PA 19355 |
Change in the endotoxin assay. |
| P060030/S004 7/30/09 |
Cobas AmpliPrep/Cobas TaqMan HCV Test | Roche Molecular Systems, Inc. Pleasanton, CA 94588 |
Elimination of functional release testing for the final bulk materials prior to filling. |
| P060037/S011 7/6/09 |
Nexgen LPS-Flex/LPS-Mobile Bearing Knee | Zimmer, Inc. Warsaw, IN 46581 |
Changes in the shell dipping process for the device. |
| P070014/S002 7/17/09 |
Bard® LifeStent® Vascular Stent Systems | Bard Peripheral Vascular Stent Systems | Modification of the quality control inspection testing on post-sterile devices. |
| P070015/S019 7/2/09 |
Xience V® and Promus™ Everolimus Eluting Coronary Stent Systems (EECSS) | Abbott Vascular Santa Clara, CA 95054 |
Change to a material specification acceptance limit. |
| P070015/S021 7/17/09 |
Xience V® and Promus™ Everolimus Eluting Coronary Stent Systems (EECSS) | Abbott Vascular Temecula, CA 92590 |
Modification to the bioburden testing frequency. |
| P080010/S003 7/17/09 |
Tecnis Multifocal Silicone and Foldable Acrylic IOL, Model ZM900 and Model ZMA00 | Abbott Medical Optics, Inc. Santa Ana, CA 92705 |
Change in the sterilization process parameters for the device. |
| P080010/S004 7/23/09 |
Tecnis Multifocal 3-Piece Foldable Posterior Chamber Intraocular Lens, Models ZM900 and ZMA00 | Abbott Medical Optics, Inc. Santa Ana, CA 92705 |
Change in the ethylene oxide residuals testing. |
| P080014/S001 7/22/09 |
Cervista HPV HR | Hologic, Inc. Marlborough, MA 01752 |
Additional supplier for Cervista HPV HR Oligo Mixes 1, 2, and 3. |
Summary of PMA Originals & Supplements Approved
Originals: 1
Supplements: 71
Summary of PMA Originals Under Review
Total Under Review: 70
Total Active: 37
Total On Hold: 33
Number Greater Than 180 Days: 4
Summary of PMA Supplements Under Review
Total Under Review: 432
Total Active: 291
Total On Hold: 141
Number Greater Than 180 Days: 15
Summary of All PMA Submissions Received
Originals: 3
Supplements: 97
Summary of PMA Supplement PMA Approval/Denial Decision Times
Number of Approvals: 71
Number of Denials: 0
Average Days Fr Receipt to Decision (Total Time): 173.5
FDA Time: 96.3 Days MFR Time: 77.2 Days
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