Medical Devices
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August 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
None.
PMA Supplemental Approvals
| APPLICATION NUMBER / DATE of APPROVAL | DEVICE TRADE NAME | COMPANY NAME CITY, STATE, & ZIP | DEVICE DESCRIPTION / INDICATIONS |
|---|---|---|---|
| P840064/S040 8/13/09 135-Day |
VISCOAT®, DUOVISC® and DISCOVISC® Ophthalmic Viscosurgical Device. | Alcon Research, Ltd. Fort Worth, TX 76134 |
Approval for an alternate clean room for aseptic filling as part of a general manufacturing plant expansion. |
| P860004/S109 8/6/09 Special |
Medtronic Model 8472 IsoMed Constant-Flow Pump | Medtronic Neurological Minneapolis, MN 55432 |
Approval for an Errata insert communicating the incompatibility issue of the sutureless connectors to the Model 8472 IsoMed constant-flow pump. |
| P860008/S019 8/18/09 Special |
CardioCommand Esophageal Bipolar Pacing and Recording Catheter | CardioCommand, Inc. Tampa, FL 33607 |
Approval for modification of the labeling to enhance the safety in the use of the products. |
| P880003/S098 8/13/09 Special |
FireStar RX PTCA Balloon Dilatation Catheter and DuraStar RX PTCA Balloon Dilatation Catheter | Cordis Corporation Bridgewater, NJ 08807 |
Approval for the modification of a caution statement in the IFU fo the device. |
| P890003/S165 8/5/09 135-Day |
Prodigy Implantable Pulse Generator (IPG) | Medtronic, Inc. Mounds View, MN 55112 |
Approval for changing a sterilization specification for finished device manufacturing. |
| P890047/S028 8/13/09 135-Day |
PROVISC® Ophthalmic Viscosurgical Device. | Alcon Research, Ltd. Fort Worth, TX 76134 |
Approval for an alternate clean room for aseptic filling as part of a general manufacturing plant expansion. |
| P890064/S020 8/12/09 180-Day |
Hybrid Capture® High-Risk HPV DNA Test® and Hybrid Capture® HPV DNA Test® DML 3000™ Microplate Luminometer | Qiagen, Inc. Gaithersburg, MD 20878 |
Approval for a manufacturing site located at Turner BioSystems in Sunnyvale, California, to manufacture the DML 3000™ Microplate Luminometer which is intended for use with the Hybrid Capture 2 High Risk HPV DNA Test and Hybrid Capture 2 HPV DNA Test. |
| P930021/S012 8/21/09 180-Day |
Straumann® Emdogain | Straumann USA Andover, MA 01810 |
Approval for a manufacturing site located at IBA Sterigenics Wallonie, S.A., in Verviers, Belgium, for the contract sterilization of the device. |
| P940015/S015 8/20/09 Real-Time |
Synvisc | Genzyme Corporation Cambridge, MA 02142 |
Approval for labeling changes to the product leaflet/package insert for Synvisc to maintain consistency with wording previously approved for Synvisc-One package inserts. |
| P950005/S025 8/10/09 180-Day |
Celsius RMT Catheter | Biosense Webster, Inc. Diamond Bar, CA 91765 |
Approval for a three (3) year shelf life for the catheter. |
| P960040/S175 8/18/09 Real-Time |
Confient SW | Boston Scientific Corporation St. Paul, MN 55112 |
Approval for the Programmer SW Model 2888 v1.08 and Programmer Model 2945 v1.02. |
| P970008/S045 8/27/09 Real-Time |
Urologix Targis® System | Urologix, Inc. Minneapolis, MN 55447 |
Approval to replace an obsolete connector used in the Targis® and CTC Advance treatment catheters and to improve the connector junction in the CTC Advance catheters |
| P970012/S052 8/5/09 135-Day |
Kappa 400 DR IPG, Kappa 400 SR IPG | Medtronic, Inc. Mounds View, MN 55112 |
Approval for changing a sterilization specification for finished device manufacturing. |
| P970051/S048 8/28/09 180-Day |
Nucleus 24 Cochlear Implant System | Cochlear Americas Centennial, CO 80111 |
Approval for the CI512 and CI513 cochlear implants. The CI512 and CI513 implants represent modifications to the Nucleus Freedom Cochlear Implant (also called the CI24RE). |
| P970051/S049 8/24/09 180-Day |
Nucleus Cochlear Implant System | Cochlear Americas Centennial, CO 80111 |
Approval for the following new components of the cochlear implant system: CP810 Sound Processor, CR110 Remote Assistant, Custom Sound 3.0 programming software. |
| P980016/S181 8/5/09 135-Day |
Marquis Implantable Cardioverter Defibrillator (ICD) Family, Maximo ICD Family, Intrinsic ICD Family, EnTrust ICD Family, Virtuoso ICD Family, Maximo II ICD Family and Secura ICD Family | Medtronic, Inc. Mounds View, MN 55112 |
Approval for changing a sterilization specification for finished device manufacturing. |
| P980035/S130 8/5/09 135-Day |
Kappa 600/700, 650, 800/900 IPG Family, Sigma IPG Family, Medtronic 350 IPG Series, Relia IPG Family, EnPulse II IPG Family, Adapta/Versa/ Sensia IPG Family and EnRhythm IPG | Medtronic, Inc. Mounds View, MN 55112 |
Approval for changing a sterilization specification for finished device manufacturing. |
| P980037/S032 8/7/09 Real-Time |
AngioJet® Rheolytic™ Thrombectomy System | MEDRAD Interventional/ Possis Minneapolis, MN 55433 |
Approval for changes to the high pressure seal component of the AngioJet Ultra Thrombectomy Sets. |
| P990001/S051 8/5/09 135-Day |
Dema Family, C-series and T-series |
Medtronic, Inc. Mounds View, MN 55112 |
Approval for changing a sterilization specification for finished device manufacturing. |
| P990025/S017 8/10/09 180-Day |
Navistar RMT Catheter | Biosense Webster, Inc. Diamond Bar, CA 91765 |
Approval for a three (3) year shelf life for the catheter. |
| P990034/S013 8/6/09 Special |
Medtronic Model 8472 IsoMed Constant-Flow Pump | Medtronic Neuromodulation Minneapolis, MN 55432 |
Approval for an Errata insert communicating the incompatibility issue of the sutureless connectors to the Model 8472 IsoMed constant-flow pump. |
| P990050/S007 8/27/09 Real-Time |
WavSTAT® Optical Biopsy System | SpectraScience, Inc. San Diego, CA 92121 |
Approval for minor design changes due to the hardware parts’ obsolescence, minor labeling changes to reflect the changes in the hardware, and a software change to update the operating system. |
| P010012/S191 8/18/09 Real-Time |
Livian SW | Boston Scientific Corporation St. Paul, MN 55112 |
Approval for the Programmer SW Model 2888 v1.08 and Programmer Model 2945 v1.02. |
| P010015/S063 8/5/09 135-Day |
InSync Cardiac Resynchronization Therapy Pacing (CRT-P), InSync III CRT-P | Medtronic, Inc. Mounds View, MN 55112 |
Approval for changing a sterilization specification for finished device manufacturing. |
| P010030/S011 8/17/09 180-Day |
Lifevest Wearable Defibrillator 4000 | Zoll Lifecor Corporation Pittsburgh, PA 15238 |
Approval for the next generation of wearable defibrillators designed to be smaller, lighter, and more user-friendly. The device, as modified, will be marketed under the trade name Lifevest Wearable Defibrillator and is indicated for adult patients who are at risk for sudden cardiac arrest and are not candidates for or refuse an implantable defibrillator. |
| P010031/S145 8/5/09 135-Day |
InSync ICD, InSync Marquis ICD, and InSync II Marquis ICD, InSync III Marquis ICD, InSync II Protect ICD, InSync III Protect ICD, InSync Sentry ICD Family, InSync Maximo ICD Family, Concerto Cardiac Resynchronization Therapy-Defibrillator (CRT-D), Maximo II CRT-D, Consulta CRT-D |
Medtronic, Inc. Mounds View, MN 55112 |
Approval for changing a sterilization specification for finished device manufacturing. |
| P020014/S024 8/26/09 135-Day |
Conceptus Essure™ System | Conceptus, Inc. Mountain View, CA 94041 |
Approval for an alternate supplier for the wound inner/outer coil (precision wire components) of the device. |
| P030029/S006 8/20/09 180-Day |
ADVIA Centaur Anti-HBs | Siemens Healthcare Diagnostics Tarrytown, NY 10591 |
Approval fot the ADVIA Centaur System Software Version 4.0. |
| P030029/S007 8/19/09 180-Day |
ADVIA Centaur XP Software v6.0 Anti-HBs | Siemens Healthcare Diagnostics Tarrytown, NY 10591 |
Approval for the ADVIA Centaur XP system Software Version 6.0. |
| P030031/S014 8/12/09 180-Day |
NaviStar and Celsius ThermoCool® Catheters | Biosense Webster Diamond Bar, CA 91765 |
Approval of the post-approval study protocol. |
| P030040/S005 8/20/09 180-Day |
ADVIA Centaur Anti-HBc IgM | Siemens Healthcare Diagnostics Tarrytown, NY 10591 |
Approval fot the ADVIA Centaur System Software Version 4.0. |
| P030040/S006 8/19/09 180-Day |
ADVIA Centaur XP Software v6.0 HBc IgM | Siemens Healthcare Diagnostics Tarrytown, NY 10591 |
Approval for the ADVIA Centaur XP system Software Version 6.0. |
| P030049/S005 8/20/09 180-Day |
ADVIA Centaur HBsAg (HBs) and HBsAg Confirmatory | Siemens Healthcare Diagnostics Tarrytown, NY 10591 |
Approval fot the ADVIA Centaur System Software Version 4.0. |
| P030049/S007 8/19/09 180-Day |
ADVIA Centaur XP Software v6.0 HBsAg (HBs) & HBsAg Confirmatory | Siemens Healthcare Diagnostics Tarrytown, NY 10591 |
Approval for the ADVIA Centaur XP system Software Version 6.0. |
| P030050/S004 8/17/09 180-Day |
Sculptra | Sanofi Aventis Bridgewater, NJ 08807 |
Approval of the post-approval study protocol. |
| P030053/S006 8/24/09 180-Day |
Memory Gel Silicone Gel-Filled Breast Implant | Mentor Corporation Santa Barbara, CA 93111 |
Approval for labeling changes after focus group input. |
| P030056/S002 8/13/09 180-Day |
ADVIA Centaur HCV ReadyPack Reagents on the Centaur CP Analyzer ADVIA Centaur HCV Quality Controls on the Centaur CP Analyzer |
Siemens Healthcare Diagnostics Tarrytown, NY 10591 |
Approval for the transition of the ADVIA Centaur HCV assay to a new platform in the Centaur family of instruments, the Centaur CP. ADVIA Centaur HCV ReadyPack Reagents on the Centaur CP Analyzer The ADVIA Centaur HCV assay is an in vitro diagnostic immunoassay for the qualitative determination of immunoglobulin G (IgG) antibodies to hepatitis C virus (HCV) in human serum and plasma (EDTA, lithium or sodium heparinized) using the ADVIA Centaur CP system. The assay may be used in conjunction with other serological and clinical information to aid in the diagnosis of individuals with symptoms of hepatitis and in individuals at risk for hepatitis C infection. ADVIA Centaur HCV Quality Controls on the Centaur CP Analyzer The ADVIA Centaur HCV Quality Controls are intended for in vitro diagnostic use in monitoring the performance of the HCV assay on the ADVIA Centaur Systems. The performance of the HCV quality controls has not been established with any other anti-HCV assay. |
| P030056/S005 8/20/09 180-Day |
ADVIA Centaur Anti-HCV | Siemens Healthcare Diagnostics Tarrytown, NY 10591 |
Approval fot the ADVIA Centaur System Software Version 4.0. |
| P030056/S006 8/19/09 180-Day |
ADVIA Centaur XP Software v6.0 HCV | Siemens Healthcare Diagnostics Tarrytown, NY 10591 |
Approval for the ADVIA Centaur XP system Software Version 6.0. |
| P040004/S005 8/20/09 180-Day |
ADVIA Centaur Anti-HBc Total | Siemens Healthcare Diagnostics Tarrytown, NY 10591 |
Approval fot the ADVIA Centaur System Software Version 4.0. |
| P040004/S006 8/19/09 180-Day |
ADVIA Centaur XP Software v6.0 HBc Total | Siemens Healthcare Diagnostics Tarrytown, NY 10591 |
Approval for the ADVIA Centaur XP system Software Version 6.0. |
| P040013/S014 8/12/09 180-Day |
GEM 21S® Growth Factor Enhanced Matrix | Luitpold Pharmaceuticals, Inc. Valley Forge, PA 19403 |
Approval for a manufacturing site located in Shirley, New York, for the manufacture of the recombinant human platelet-derived growth factor-BB syringe and a quality testing facility at another location in Shirley, New York, for the testing for the raw material, finished product release, and stability with the exception of the bioassay for the drug component of the device. |
| P040020/S014 8/20/09 180-Day |
Acrysof® IQ ReSTOR® Intraocular Lenses (IOLs) +3 D and +4 D Add Powers |
Alcon Research Ltd. Fort Worth, TX 76134 |
Approval for changes to the labeling, revising the Directions for Use (DFU) and patient brochure with updated six-month follow up data from the clinical investigation for the lenses. The devices, as modified will be marketed under the trade name Acrysof® IQ ReSTOR® Intraocular Lenses (IOLs) +3.0 D (Models: SN6AD1 and MN6AD1) and +4.0 D (Models: SN6AD3 and MN6AD3) Add Powers and is indicated for primary implantation for the visual correction of aphakia secondary to removal of a cataractous lens in adult patients with or without presbyopia, who desire near, intermediate and distance vision with increased spectacle independence. The lens is intended to be placed in the capsular bag. |
| P040044/S016 8/4/09 Real-Time |
Mynx Vascular Closure Device | Access Closure, Inc. Mountain View, CA 94043 |
Approval for changing the lid component of the Mynx packaging, from Tyvek material to a PETG material lid. |
| P040048/S008 8/27/09 180-Day |
Trilogy AB Acetabular System | Zimmer, Inc. Warsaw, IN 46581 |
Approval for a manufacturing site located in Marktredwitz, Germany. |
| P050004/S001 8/28/09 180-Day |
EMS Swiss DolorClast® | Electro Medical Systems Nyon, Switzerland CH-1260 |
Approval for a manufacturing site located at E.M.S. Electro Medical Systems, SA, Nyon, Switzerland. |
| P050014/S002 8/11/09 Special |
FCRMS | Fujifilm Medical System USA, Inc. Stamford, CT 06902 |
Approval for: 1) changes in the CNR Weekly check – QC Technologist; 2) change to the Monitor QC – Medical Physicist Test luminance response test; 3) new terminology regarding use of the term “acquisition workstation); and 4) trade name change to “Aspire”. |
| P050047/S008 8/26/08 Real-Time |
Juvederm Hyaluronate Gel Implants | Allergan Santa Barbara, CA 93111 |
Approval for an addition of 0.4 mL filled syringe configuration. |
| P060038/S004 8/28/09 135-Day |
Mitroflow Aortic Pericardial Heart Valve | CarboMedics, Inc. Arvada, CO 80004 |
Approval for the addition of a new bovine pericardium supplier used in the manufacture of the device. |
| P080004/S001 8/7/09 180-Day |
Hoya iSpheric™ Model YA-60BB Intraocular Lens | Hoya Surgical Optics, Inc. Chino Hills, CA 91709 |
Approval to add a new packaging configuration wherein the Hoya Surgical Optics intraocular lenses (IOLs) will be packaged in a disposable, plastic injector. |
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 |
| P860004/S110 8/20/09 |
SynchroMed II Infusion System | Medtronic Neuromodulation Minneapolis, MN 55432 |
Automation of the step where data is transferred from the Calibration Testing Equipment to FACTORYWorks, the manufacturing software that controls the manufacturing of the device. |
| P910031/S026 8/26/09 |
NC Merlin Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter | Abbott Vascular, Inc. Temecula, CA 92591 |
Change in the equipment used to manufacture the balloons. |
| P960013/S048 8/28/09 |
Tendril ST Lead | St. Jude Medical, Inc. Sylmar, CA 91342 |
Elimination of the plasma priming process. |
| P960043/S066 8/24/09 |
Suture Mediated Closure Systems, Percutaneous Vascular Surgical Systems and Associated Accessories | Abbott Vascular, Inc. Redwood City, CA 94063 |
Additional equipment for use in the packaging stations. |
| D970012/S068 8/5/09 |
AMS 700 Inflatable Penile Prosthesis | American Medical Systems Minnetonka, MN 55343 |
Upgrading of the heating system used in the manufacture of the device. |
| D970012/S069 8/13/09 |
AMS 700 Inflatable Penile Prosthesis | American Medical Systems Minnetonka, MN 55343 |
Implementation of a new duplicate mold. |
| D970012/S070 8/26/09 |
AMS 700 Inflatable Penile Prosthesis | American Medical Systems Minnetonka, MN 55343 |
Replacement of dipping equipment used in the manufacture of the devices. |
| P980016/S199 8/21/09 |
Maximo, Secura and Virtuoso II Families of Implantable Cardioverter Defibrillators | Medtronic, Inc. Mounds View, MN 55112 |
Several changes to D363 IC test. |
| P980022/S057 8/13/09 |
MMT-7002 and MMT-7003 | Medtronic, Inc. Diabetes Northridge, CA 91325 |
Addition of an additional electroplating line for the sensors. |
| P980022/S058 8/21/09 |
Paradigm Real-Time Pump and Guardian Real-Time Monitor – EL Lamp | Medtronic, Inc. Diabetes Northridge, CA 91325 |
Changes to the Electro Luminescent Lamp (EL Lamp). |
| P000053/S025 8/5/09 |
AMS 800 Artificial Urinary Sphincter | American Medical Systems Minnetonka, MN 55343 |
Upgrading of the heating system used in the manufacture of the device. |
| P000053/S026 8/13/09 |
AMS 800 Artificial Urinary Sphincter | American Medical Systems Minnetonka, MN 55343 |
Replacement of dipping equipment used in the manufacture of the devices. |
| P010020/S014 8/13/09 |
Acticon Neosphincter Artificial Bowel Sphincter | American Medical Systems Minnetonka, MN 55343 |
Replacement of dipping equipment used in the manufacture of the devices. |
| P010031/S160 8/21/09 |
Maximo, Secura and Virtuoso II Families of Implantable Cardioverter Defibrillators | Medtronic, Inc. Mounds View, MN 55112 |
Several changes to D363 IC test. |
| P020004/S047 8/21/09 |
Gore Excluder® AAA Endoprosthesis | W.L. Gore & Associates, Inc. Flagstaff, AZ 86001 |
Expansion of the manufacturing environment for a component of the final device. |
| P030017/S094 8/18/09 |
Precision Spinal Cord Stimulator System (SCS) | Boston Scientific Neuromodulation Corporation Valencia, CA 91355 |
Modification to the lead assembly process. |
| P040012/S030 8/5/09 |
RX Acculink and Acculink Carotid Stent System | Abbott Vascular, Inc. Santa Clara, CA 95054 |
Expansion of the Acculink manufacturing processes within the existing manufacturing facility in Temecula, California. |
| P040014/S011 8/28/09 |
Therapy Cardiac Ablation Catheter | St. Jude Medical Irvine, CA 92614 |
Change in the proximal component of the ablation catheters. |
| P040024/S042 8/6/09 |
Restylane® and Perlane® Injectable Gel | Medicis Pharmaceutical Corp. Scottsdale, AZ 85256 |
Alternate endotoxin test method. |
| P040024/S043 8/14/09 |
Restylane® and Perlane® Injectable Gel | Medicis Pharmaceutical Corp. Scottsdale, AZ 85256 |
Elimination of the sterilization of garments before use. |
| P040034/S012 8/28/09 |
DuraSeal® Dural Sealant System | Confluent Surgical, Inc. (dba Covidien) Waltham, MA 02451 |
Alternate supplier to provide the functionalized PEG-SG material to the firm for use in the manufacture of the device. |
| P040042/S016 8/28/09 |
Therapy Dual 8, Therapy and Safire TX Ablation Catheter | St. Jude Medical Irvine, CA 92614 |
Change in the proximal component of the ablation catheters. |
| P040044/S017 8/7/09 |
Mynx® Vascular Closure Device | Access Closure, Inc. Mountain View, CA 94043 |
Reduction in the frequency of LAL test sampling for lot release for the device. |
| P040045/S006 8/7/09 |
Vistakon® (senofilcon A) Contact Lenses for Extended Wear | Johnson & Johnson Vision Care, Inc. Jacksonville, FL 32256 |
Change in a Quality Control Test for the finished device. |
| P040045/S008 8/6/09 |
Vistakon® (senofilcon A) Contact Lenses | Johnson & Johnson Vision Care, Inc. Jacksonville, FL 32256 |
Change in a quality control test method for the finished device. |
| P050006/S013 8/7/09 |
Gore HELEX™ Septal Occluder | W.L. Gore & Associates, Inc. Flagstaff, AZ 86001 |
Relocation of manufacturing from one facility to another within the same registered establishment. |
| P050007/S017 8/13/09 |
StarClose SE® Vascular Closure System | Abbott Vascular, Inc. Redwood, CA 94063 |
Addition of an alternate assembly step to the manufacturing process for the obturator release rod assembly. |
| P050007/S018 8/24/09 |
StarClose and StarClose SE® Vascular Closure Systems | Abbott Vascular, Inc. Redwood City, CA 94063 |
Additional equipment for use in the packaging stations. |
| P050020/S018 8/21/09 |
Freestyle Navigator® Continuous Glucose Monitoring System | Abbott Diabetes Care, Inc. Alameda, CA 94502 |
Changes to the parameters of the transmitter bottom housing mold. |
| P060033/S037 8/14/09 |
Endeavor Zotarolimus-Eluting Coronary Stent Systems | Medtronic Vascular Santa Rosa, CA 95403 |
Additional automation of the balloon sub-assembly manufacturing process. |
| P060038/S005 8/7/09 |
Mitroflow Aortic Pericardial Heart Valve | CarboMedics, Inc. Arvada, CO 80004 |
Change in the minimum exposure time for the sterilization process of the device. |
| P060038/S006 8/14/09 |
Mitroflow Aortic Pericardial Heart Valve | CarboMedics, Inc. Arvada, CO 80004 |
Change to the base seam stitching pattern. |
| P070009/S005 8/25/09 |
Realize™ Adjustable Gastric Band-C | Ethicon Endo-Surgery, Inc. Cincinnati, OH 45242 |
Addition of an alternate component supplier. |
| P070015/S023 8/26/09 |
Xience V® OTW Everolimus Eluting Coronary Stent System (EECSS) | Abbott Vascular, Inc. Temecula, CA 92592 |
Replacement of the E-beam irradiation equipment. |
Summary of PMA Originals & Supplements Approved
Originals: 0
Supplements: 50
Summary of PMA Originals Under Review
Total Under Review: 73
Total Active: 40
Total On Hold: 33
Number Greater Than 180 Days: 5
Summary of PMA Supplements Under Review
Total Under Review: 436
Total Active: 293
Total On Hold: 143
Number Greater Than 180 Days: 19
Summary of All PMA Submissions Received
Originals: 4
Supplements: 37
Summary of PMA Supplement PMA Approval/Denial Decision Times
Number of Approvals: 50
Number of Denials: 0
Average Days Fr Receipt to Decision (Total Time): 162.6
FDA Time: 119 Days MFR Time: 43.6 Days
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