Medical Devices
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September 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 |
|---|---|---|---|
| P080013 9/4/09 |
DuraSeal Xact™ Sealant System | Confluent Surgical, Inc. Waltham, MA 02451 | Approval for the DuraSeal Xact™ Sealant System. The device is indicated for use as an adjunct to sutured dural repair during spinal surgery to provide watertight closure. |
PMA Supplemental Approvals
| APPLICATION NUMBER / DATE of APPROVAL | DEVICE TRADE NAME | COMPANY NAME CITY, STATE, & ZIP | DEVICE DESCRIPTION / INDICATIONS |
|---|---|---|---|
| P830055/S111 9/16/09 Real-Time |
LCS Total Knee System | DePuy Orthopaedics, Inc. Warsaw, IN 46581 |
Approval for the addition of the Sigma PS (Lugged and Non-Lugged) Femoral Components as compatible components with the MBT Tibial Trays (cemented, keeled, porous), the MBT Tibial Trays (cemented), and the Sigma RP PS Tibial Inserts. |
| P840001/S135 9/2/09 135-Day |
Titan Anchor | Medtronic Neuromodulation Minneapolis, MN 55432 |
Approval for: 1) removal of the xylene mixing step; 2) addition of a secondary silicone adhesive step and cure; and 3) modification of the incoming receiving inspection process with the addition of a process monitor. |
| P860003/S054 9/15/09 135-Day |
Therakos CellEx Photopheresis System | Therakos, Inc. Exton, PA 19341 |
Approval for the transfer of finished product testing to SteriPro Labs from Therakos, Inc. |
| P860004/S108 9/4/09 Real-Time |
Medtronic SynchroMed II Implantable Infusion Pump System | Medtronic, Inc. Minneapolis, MN 55432 |
Approval for: 1) Updated manuals with the general term "plastic" to describe the new hub/cap material and added other minor clarifications; 2) Added compartment to form an inner tray to contain accessories - eliminates bagging and reduces manufacturing cost; 3) Inner tray is placed in an outer tray and sealed with a polyethylene lid; 4) Inner tray, inner lid and outer tray material changed to polyethylene terephthalate (PET) for improved recycling; and 5) Modified box to accommodate new tray design and additional (European) languages in Manuals. |
| P860019/S234 9/18/09 135-Day |
Maverick 2™ Monorail (MR), Maverick® Over-the-Wire (OTW), Quantum® Maverick MR and OTW | Boston Scientific Corporation Maple Grove, MN 55311 |
Approval for changes to the silicone material. |
| P860019/S237 9/22/09 135-Day |
Apex PTCA Balloon Dilatation Catheter | Boston Scientific Corporation Maple Grove, MN 55311 |
Approval for changes to the bonding process. |
| P860057/S059 9/18/09 180-Day |
Carpentier-Edwards Perimount Plus Pericardial Bioprosthesis | Edwards Lifesciences, LLC Irvine, CA 92614 |
Approval for updated labeling to reflect findings of post-market clinical study 98-1. |
| P890003/S173 9/25/09 Real-Time |
Medtronic Carelink Home Monitor | Cardiac Rhythm Disease Management Mounds View, MN 55112 |
Approval for Cellular Connectivity for Remote Monitoring, with the Model 2490 Medtronic CareLink Home Monitor. |
| P950022/S063 9/29/09 Real-Time |
Durata, Riata, Riata ST and Riata ST Optim Families of Leads | St. Jude Medical, Inc. Cardiac Rhythm Management Division Sylmar, CA 91342 |
Approval for design and process modifications of the DR-1 connector pin on the Durata, Riata, Riata ST and Riata ST Optim families of leads. |
| P980035/S140 9/25/09 Real-Time |
Adapta, Versa, Sensia and Relia Family of Pacemakers | Medtronic, Inc. Minneapolis, MN 55112 |
Approval for design changes to the L368 integrated circuit including modifications to the charge amp offset circuit, autopolarity short circuit pace threshold circuit, and Keithley structure as well as a family identification change in the integrated circuit for the Relia. |
| P980043/S021 9/29/09 Real-Time |
Hancock® II Bioprosthesis | Medtronic Heart Valves Santa Ana, CA 92705 |
Approval for a design modification to the disposable CINCH aortic valve holder. The device, as modified, will be marketed under the trade name CINCH II valve holder and is indicated for the temporary deflection of the valve stent posts to provide surgical ease of implantation of the bioprosthesis. |
| P980052/S004 9/2/09 180-Day |
Patient-Fitted TMJ Reconstruction Prosthesis System | TMJ Concepts Ventura, CA 93003 |
Approval for modified labeling to reflect post approval study findings. |
| P990064/S028 9/29/09 Real-Time |
Mosaic® Porcine Bioprosthesis | Medtronic Heart Valves Santa Ana, CA 92705 |
Approval for a design modification to the disposable CINCH aortic valve holder. The device, as modified, will be marketed under the trade name CINCH II valve holder and is indicated for the temporary deflection of the valve stent posts to provide surgical ease of implantation of the bioprosthesis. |
| P000025/S041 9/3/09 135-Day |
COMBI 40+ Cochlear Implant System | MED-EL Corporation Durham, NC 27713 |
Approval for the addition of a second source supplier for the Feedthrough Assembly. |
| P000025/S043 9/23/09 Real-Time |
SONATA TI 100 Implant | MED-EL Corporation Durham, NC 27713 |
Approval for the creation of a fitting guide for MAESTRO 3.0 and the speech processors OPUS1 and OPUS2. |
| P010013/S022 9/15/09 180-Day |
NovaSure Impedance Controlled Endometrial Ablation System | Hologic, Inc. Marlborough, MA 01752 |
Approval for a contract sterilization site located at Steris-Isomedix, Northborough, Massachusetts. |
| P020026/S017 9/18/09 180-Day |
2.25 mm CYPHER® Stent on RAPTORRAIL® RX SDS | Cordis Corporation Miami, FL 33102 |
Approval for the 2.25 mm CYPHER Stent on RAPTORRAIL RX Stent Delivery System. The device, as modified, will be marketed under the trade name CYPHER and is indicated for improving coronary luminal diameter in patients with symptomatic ischemic disease due to discrete de novo lesions of length <= 30 mm in native coronary arteries with a reference vessel diameter of >=2.25 to <=3.50 mm. |
| P030024/S010 9/11/09 180-Day |
VITROS Immunodiagnostic Products anti-HBc Reagent Pack and VITROS Immunodiagnostic Products anti-HBc Calibrator | Ortho-Clinical Diagnostics, Inc. Rochester, NY 14626 |
Approval for the revision of the Intended Use to include user of the VITROS 5600 Integrated System and VITROS 3600 Immunodiagnostic System with the Anti-HBc Assay. The device, as modified, will be marketed under the trade name VITROS Immunodiagnostic Products anti-HBc Reagent Pack and VITROS Immunodiagnostic Products anti-HBc Calibrator and is indicated for: VITROS Immunodiagnostic Products anti-HBc Reagent Pack: For the in vitro qualitative detection of total antibody (lgG and IgM) to hepatitis B core antigen (total anti-HBc) in human adult and pediatric serum and plasma (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, or recovery from hepatitis B infection. The presence of anti-HBc may be used as an aid in the determination of exposure to HBV infection for individuals prior to HBV vaccination. VITROS Immunodiagnostic Products Anti-HBc 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 total antibody (IgG and IgM) to hepatitis B virus core antigen (total anti HBc) in human adult and pediatric serum and plasma (EDTA and citrate) and neonate serum using VITROS Anti-HBc IgM Reagent Packs. The VITROS Anti-HBc 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 Reagent Packs. |
| P030039/S013 9/3/09 135-Day |
Coseal Surgical Sealant | Baxter Healthcare Corporation McGaw Park, IL 60085 |
Approval for a new supplier of PEG component material. |
| P030049/S002 9/25/09 180-Day |
ADVIA Centaur HBsAg ReadyPack Reagents on the Centaur CP Analyzer ADVIA Centaur HBsAg Confirmatory ReadyPack Reagents on the Centaur CP Analyzer HBsAg Quality Controls on the Centaur CP Analyzer |
Siemens Healthcare Diagnostics Tarrytown, NY 10591 |
Approval for the transition of the ADVIA Centaur HBsAg assay and the ADVIA Centaur HBsAg Confirmatory assay to a new platform in the Centaur family of instruments, The Centaur CP. ADVIA Centaur HBsAg ReadyPack Reagents on the Centaur CP Analyzer: The ADVIA Centaur HBsAg Assay is an in vitro diagnostic immunoassay for the qualitative detection of hepatitis B surface antigen (HBsAg) in human serum and plasma (potassium 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 diagnose individuals with acute or chronic hepatitis B infection. The assay may also be used to screen for hepatitis B infection in pregnant women to identify neonates who are at risk of acquiring hepatitis B during the perinatal period. The ADVIA Centaur HBsAg Confirmatory Assay ReadyPack on the Centaur CP Analyzer: The ADVIA Centaur HBsAg Confirmatory Assay is an in vitro diagnostic immunoassay for the qualitative confirmation of the presence of hepatitis B surface antigen (HBsAg) in human serum and plasma (potassium EDTA, lithium or sodium heparin) using the ADVIA Centaur CP system. The assay is intended to be used to confirm the presence of HBsAg in samples that are repeatedly reactive using the ADVIA Centaur HBsAg Assay. ADVIA Centaur HBsAg Quality Controls on the Centaur CP Analyzer: For monitoring the performance of the HBsAg and HBsAg Confirmatory assays on the ADVIA Centaur® systems. The performance of the HBsAg quality control material has not been established with any other HBsAg or HBsAg Confirmatory assays. |
| P040002/S025 9/16/09 180-Day |
PowerLink System with IntuiTrak Delivery System | Endologix, Inc. Irvine, CA 92618 |
Approval for changes made to the labeling to include instructions for the option of deploying of the ipsilateral leg first. |
| P040016/S037 9/25/09 Special |
VeriFLEX Bare Metal Coronary Stent | Boston Scientific Corporation Maple Grove, MN 55311 |
Approval to add an alternate trade name for the Liberté Monorail and Over-the-Wire Coronary Stent Systems. The device will be marketed under the trade name VeriFLEX Bare Metal Coronary Stent and is indicated for improving coronary luminal diameter in patients with symptomatic ischemic disease with stenotic lesions in native coronary arteries (length <28 mm) with a reference vessel diameter of 2.75 to 5.00 mm. |
| P040025/S009 9/18/09 Real-Time |
Olympic Cool-Cap® System | Natus Medical Inc. Seattle, WA 98108 |
Approval for the Cool-Cap 1.1.1 software. |
| P050019/S001 9/25/09 180-Day |
Carotid Wallstent® Monorail® Endoprosthesis | Boston Scientific Mountain View, CA 94043 |
Approval of the post-approval study protocol. |
| P050020/S010 9/25/09 180-Day |
FreeStyle Navigator Continuous Glucose Monitoring System | Abbott Diabetes Care, Inc. Alameda, CA 94502 |
Approval new packaging and desiccant for the inserter subcomponent of the Sensor Delivery Unit (SDU), which is a component of the FreeStyle Navigator Continuous Glucose Monitoring System. This modification to the original approved device results in a new sterilization configuration, a new package and new sterilization method (EO) for the sensor support mount subcomponent of the SDU, user assembly of the inserter with the sensor support mount Section, new secondary containers for the subcomponents of the SDU Section, and changes to SDU labeling corresponding to the packaging changes. |
| P060002/S005 9/4/09 180-Day |
FLAIR™ Endovascular Stent Graft | C.R. Bard, Inc. Tempe, AZ 85281 |
Approval of the post-approval study protocol. |
| P070015/S014 9/11/09 135-Day |
XIENCE V™ and Promus™ Everolimus Eluting Coronary Stent Systems | Abbott Vascular, Inc. Temecula, CA 92591 |
Approval for a change to in-process inspection acceptance criteria. |
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 |
| P840001/S140 9/16/09 |
Spinal Cord Stimulation Family of Neurostimulation Leads | Medtronic Neuromodulation Minneapolis, MN 55432 |
Transfer of quadrafilar coils supplier manufacturing site from Heraeus Lino Lakes, Minnesota to Dorado, Puerto Rico. |
| P850007/S029 9/11/09 |
Physio-Stim® and Spinal-Stim® | Orthofix, Inc. McKinney, TX 75069 |
Replacement of the battery cell for the line of bone growth stimulators. |
| P860004/S111 9/9/09 |
SynchroMed II Infusion System | Medtronic Neuromodulation Minneapolis, MN 55432 |
Automating the step where data is transferred from the Alarm Test Equipment to FACTORYWorks, the manufacturing software that controls the manufacturing of the device. |
| P860004/S112 9/18/09 |
SynchroMed II Infusion System | Medtronic Neuromodulation Minneapolis, MN 55432 |
Automation of the transfer of final functional test data to FACTORYWorks, the manufacturing software that controls the manufacturing of the device. |
| P860019/S238 9/8/09 |
Apex PTCA Balloon Dilatation Catheter | Boston Scientific Corporation Maple Grove, MN 55311 |
Alternate distal welding process. |
| P860019/S240 9/30/09 |
Quantum Maverick and Maverick OTW PTCA Catheters | Boston Scientific Corporation Maple Grove, MN 55311 |
Elimination of an in-process cleaning of components for the device. |
| P910073/S079 9/22/09 |
Reliance Leads | Boston Scientific, Inc. St. Paul, MN 55112 |
Replacing the automated optical measuring system. |
| P950020/S034 9/30/09 |
Flextome Cutting Balloon OTW PTCA Catheter | Boston Scientific Corporation Maple Grove, MN 55311 |
Elimination of an in-process cleaning of components for the device. |
| P950022/S064 9/25/09 |
Riata, Riata ST and Durata Family of Leads | St. Jude Medical Cardiac Rhythm Management Division Sylmar, CA 91342 |
Change in temperature and humidity cure operation. |
| P950029/S045 9/4/09 |
Reply DR and Reply SR Pacemakers | ELA Medical, Inc./ Sorin Group Plymouth, MN 55441 |
Change to a visual inspection. |
| P950032/S053 9/3/09 |
Apligraf | Organogenesis, Inc. Canton, CA 02021 |
Addition of an alternate supplier intended to provide consistent supply of materials to production assemblies. |
| P960009/S069 9/16/09 |
Deep Brain Stimulation Family of Neurostimulation Leads | Medtronic Neuromodulation Minneapolis, MN 55432 |
Transfer of quadrafilar coils supplier manufacturing site from Heraeus Lino Lakes, Minnesota to Dorado, Puerto Rico. |
| P960013/S049 9/17/09 |
Tendril 1888 Lead | St. Jude Medical Cardiac Rhythm Management Division Sylmar, CA 91342 |
Addition of an oven curing step. |
| P960013/S050 9/17/09 |
Tendril 1888 Lead | St. Jude Medical Cardiac Rhythm Management Division Sylmar, CA 91342 |
Alternate supplier of outer tubing for use in the manufacturing of the leads. |
| P960013/S051 9/25/09 |
Tendril, Tendril ST and OptiSense Family of Leads | St. Jude Medical Cardiac Rhythm Management Division Sylmar, CA 91342 |
Change in temperature and humidity cure operation. |
| P960016/S024 9/30/09 |
LivewireTC™ and Safire™ Cardiac Ablation System | St. Jude Medical Atrial Fibrillation Division Minnetonka, MN 55345 |
Replacement of the Horizon test system with the Cirris Touch 1 Electrical Test System. |
| P960030/S027 9/25/09 |
Passive Plus, IsoFlex S, IsoFlex P and IsoFlex Optim Family of Leads | St. Jude Medical Cardiac Rhythm Management Division Sylmar, CA 91342 |
Change in temperature and humidity cure operation. |
| P960040/S203 9/16/09 |
Teligen Implantable Pacemaker | Boston Scientific St. Paul, MN 55112 |
Addition of a new cathode sheet manufacturing process. |
| P980016/S201 9/3/09 |
Marquis VR/DR ICD | Medtronic, Inc. Mounds View, MN 55112 |
Changes to the capacitor stack assembly process. |
| P980016/S202 9/18/09 |
Virtuoso, Virtuoso II, Secura, Maximo II Family of Implantable Cardioverter Defibrillators (ICDs) | Medtronic, Inc. Mounds View, MN 55112 |
Modifications to a final device test. |
| P980044/S010 9/25/09 |
Supartz® | Smith & Nephew, Inc. Memphis, TN 38116 |
Replacement of the filter integrity testing instrument with a newer model of the instrument. |
| P990020/S035 9/1/09 |
AneuRx AAAdvantage Stent Graft Delivery System | Medtronic Vascular Santa Rose, CA 95403 |
Alternative testing facility and changes to the sampling plan for the finished device LAL testing. |
| P990023/S007 9/3/09 |
CELLUGEL® Ophthalmic Viscosurgical Device | Alcon Research, Ltd. Ft. Worth, TX 76134 |
Alternate manufacturing process to automate the labeling, assembly, and packaging process. |
| P000006/S015 9/11/09 |
Titan Inflatable Penile Prosthesis (IPP) | Coloplast Corporation Minneapolis, MN 55411 |
Use of a different piece of equipment during the dipping process. |
| P010012/S218 9/16/09 |
Gognis Implantable Pacemaker | Boston Scientific St. Paul, MN 55112 |
Addition of a new cathode sheet manufacturing process. |
| P010031/S162 9/3/09 |
InSync II Marquis ICD, InSync Marquis, InSync III Marquis ICD, InSync II Protect ICD, InSync III Protect ICD and Intrinsic ICD | Medtronic, Inc. Mounds View, MN 55112 |
Changes to the capacitor stack assembly process. |
| P010031/S163 9/18/09 |
Concerto, Concerto II, Consulta, Maximo II Family of Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) | Medtronic, Inc. Mounds View, MN 55112 |
Modifications to a final device test. |
| P020009/S050 9/30/09 |
Express2 Coronary Stent System | Boston Scientific Corporation Maple Grove, MN 55311 |
Elimination of an in-process cleaning of components for the device. |
| P020026/S066 9/14/09 |
Cypher® Sirolimus-Eluting Coronary Stent on RAPTOR™ Over-the-Wire Delivery System and RAPTORRAIL® Rapid Exchange Delivery System | Cordis Corporation Miami Lakes, FL 33014 |
Change to a stainless steel manufacturing aid. |
| P020026/S067 9/18/09 |
Cypher® Sirolimus-Eluting Coronary Stent on RAPTOR™ Over-the-Wire Delivery System and RAPTORRAIL® Rapid Exchange Delivery System | Cordis Corporation Miami Lakes, FL 33014 |
Addition of an alternate supplier. |
| P020052/S005 9/22/09 |
Response CV Cardioversion Electrophysiology Catheter & System Accessory Equipment | St. Jude Medical St. Paul, MN 55117 |
Change in the sterilization load. |
| P030009/S035 9/15/09 |
Driver and Micro-Driver Coronary Stent Systems | Medtronic Vascular, Inc. Santa Rosa, CA 95403 |
Implementation of an alternate production aid. |
| P030022/S013 9/11/09 |
Reflection Ceramic Acetabular Hip System | Smith & Nephew Memphis, TN 38116 |
New Raw material supplier manufacturing site that will be used to forge the Anthology hip stems associated with the device. |
| P030025/S064 9/30/09 |
Taxus Express2 Paclitaxel-Eluting Coronary Stent System | Boston Scientific Corporation Maple Grove, MN 55311 |
Elimination of an in-process cleaning of components for the device. |
| P030029/S008 9/15/09 |
ADVIA Centaur aHBs Assay | Siemens Healthcare Diagnostics East Walpole, MA 02032 |
Change from 20 grams to 60 grams for the anti-HBs wetcake used in the production of aHBs reagent. |
| P030034/S003 9/11/09 |
Cervical-Stim® | Orthofix, Inc. McKinney, TX 75069 |
Replacement of the battery cell for the line of bone growth stimulators. |
| P030035/S058 9/25/09 |
Aescula Family of Left Heart Leads | St. Jude Medical Cardiac Rhythm Management Division Sylmar, CA 91342 |
Change in temperature and humidity cure operation. |
| P030054/S132 9/25/09 |
QuickSite and QuickFlex Family of Leads | St. Jude Medical Cardiac Rhythm Management Division Sylmar, CA 91342 |
Change in temperature and humidity cure operation. |
| P040016/S036 9/30/09 |
Liberté Coronary Stent System | Boston Scientific Corporation Maple Grove, MN 55311 |
Elimination of an in-process cleaning of components for the device. |
| P040021/S010 9/16/09 |
St. Jude Medical Biocor™, Biocor™ Supra, Epic™ and Epic™ Supra Heart Valves | St. Jude Medical, Inc. St. Paul, MN 55117 |
Change in raw material used to manufacture the device. |
| P040027/S017 9/23/09 |
Gore Viatorr® TIPS Endoprosthesis | W.L. Gore & Associated, Inc. Flagstaff, AZ 86002 |
Removal of the zipper component process. |
| P040037/S023 9/17/09 |
Gore Viabahn® Endoprosthesis | W.L. Gore & Associated, Inc. Flagstaff, AZ 86002 |
Discontinuance of a redundant acceptance activity. |
| P040037/S024 9/23/09 |
Gore Viabahn® Endoprosthesis | W.L. Gore & Associated, Inc. Flagstaff, AZ 86002 |
Removal of the zipper component process. |
| P050007/S019 9/1/09 |
StarClose SE® Vascular Closure System | Abbott Vascular, Inc. Redwood City, CA 94063 |
Change in the subassembly bonding process. |
| P050007/S020 9/14/09 |
StarClose SE® Vascular Closure System | Abbott Vascular, Inc. Redwood City, CA 94063 |
Change from a manual process to a semi-automated process at the Wire Controller Assembly Station. |
| P050007/S021 9/18/09 |
StarClose SE® Vascular Closure System | Abbott Vascular, Inc. Redwood City, CA 94063 |
Outsourcing a subassembly and removal of a manufacturing step. |
| P050012/S019 9/17/09 |
DexCom™ Seven® Plus System | DexCom, Inc. San Diego, CA 92121 |
Adding an additional supplier for the DexCom applicator needles. |
| P050012/S020 9/23/09 |
DexCom™ Seven® Plus System | DexCom, Inc. San Diego, CA 92121 |
Change to the process for applying the electrode layer of the sensor component. |
| P050020/S019 9/21/09 |
Freestyle Navigator® Continuous Glucose Monitoring System | Abbott Diabetes Care, Inc. Alameda, CA 94502 |
Adding an alternate manufacturer for the inserter assembly process. |
| P050039/S003 9/30/09 |
Novation Ceramic Articulation Hip System (AHS) | Exactech, Inc. Gainesville, FL 32653 |
Change from performing Fluorescent Penetrant Inspection (FPI) at QC Labs to performing the inspection step in-house as well as a process change at CeramTec. |
| P050047/S009 9/4/09 |
Juvéderm® Hyaluronate Gel Implants | Allergan Goleta, CA 93117 |
Installation of an additional manufacturing production line. |
| P060008/S019 9/30/09 |
Taxus Liberté Paclitaxel-Eluting Coronary Stent System | Boston Scientific Corporation Maple Grove, MN 55311 |
Elimination of an in-process cleaning of components for the device. |
| P060033/S039 9/3/09 |
Endeavor and Endeavor Sprint Zotarolimus-Eluting Coronary Stent Systems | Medtronic Vascular, Inc. Santa Rosa, CA 95403 |
Change in the storage time for exposed biological indicators prior to testing. |
| P060033/S041 9/15/09 |
Endeavor and Endeavor Sprint Zotarolimus-Eluting Coronary Stent System | Medtronic Vascular, Inc. Santa Rosa, CA 95403 |
Implementation of an alternate production aid. |
| P070007/S011 9/1/09 |
Talent Thoracic Stent Graft with Xcelerant Delivery System | Medtronic Vascular Santa Rose, CA 95403 |
Alternative testing facility and changes to the sampling plan for the finished device LAL testing. |
| P070014/S003 9/1/09 |
Bard® LifeStent® Vascular Stent Systems | Bard Peripheral Vascular, Inc. Tempe, AZ 85280 |
Addition of an in house supplier for sheath components and extension of the shelf life for a sheath component. |
| P070027/S010 9/1/09 |
Talent Abdominal Stent Graft with Xcelerant Delivery System | Medtronic Vascular Santa Rose, CA 95403 |
Alternative testing facility and changes to the sampling plan for the finished device LAL testing. |
Summary of PMA Originals & Supplements Approved
Originals: 1
Supplements: 27
Summary of PMA Originals Under Review
Total Under Review: 75
Total Active: 42
Total On Hold: 33
Number Greater Than 180 Days: 7
Summary of PMA Supplements Under Review
Total Under Review: 473
Total Active: 325
Total On Hold:148
Number Greater Than 180 Days: 21
Summary of All PMA Submissions Received
Originals: 2
Supplements: 85
Summary of PMA Supplement PMA Approval/Denial Decision Times
Number of Approvals: 27
Number of Denials: 0
Average Days Fr Receipt to Decision (Total Time): 157
FDA Time: 103.6 Days MFR Time: 53.4 Days
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