Medical Devices
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April 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 |
|---|---|---|---|
| P080006 4/7/09 |
Attain Ability™ Model 4196 Lead | Medtronic, Inc. Mounds View, MN 55112 |
Approval for the Attain Ability™ Model 4196 Lead. The Attain Ability™ Model 4196 steroid eluting, dual electrode, IS-1 transvenous lead is indicated for chronic pacing and sensing in the left ventricle via the cardiac vein, when used in conjunction with a compatible Medtronic Cardiac Resynchronization Therapy (CRT) system. Extended bipolar pacing is available using this lead in combination with a compatible CRT-D system and RV defibrillation lead or with a compatible CRT-P system and RV pacing lead. |
| P080023 4/10/09 |
ARCHITECT® CORE Reagent Kit, ARCHITECT® CORE Calibrator and ARCHITECT® CORE Controls | Abbott Laboratories Abbott Park , IL 60064 |
Approval for the ARCHITECT® CORE Reagent Kit, ARCHITECT® CORE Calibrator and ARCHITECT® CORE Controls. These devices are indicated for: ARCHITECT® CORE Reagent Kit: The ARCHITECT CORE assay is a chemiluminescent microparticle immunoassay (CMIA) for the qualitative detection of IgG and IgM antibodies to hepatitis B core antigen (anti-HBc) in human adult and pediatric serum and plasma (dipotassium EDTA, lithium heparin, sodium heparin) and neonatal serum. It is intended as an aid in the diagnosis of acute, chronic, or resolved hepatitis B virus (HBV) infection in conjunction with other laboratory results and clinical information. ARCHITECT® CORE Calibrator: The ARCHITECT CORE Calibrator is used for the calibration of the ARCHITECT i System when the system is used for the qualitative detection of IgG and IgM antibodies to hepatitis B core antigen (anti-HBc) with the ARCHITECT CORE Reagent Kit. The performance of the ARCHITECT CORE Calibrator has not been established with any other anti-HBc assays. ARCHITECT® CORE Controls: The ARCHITECT CORE Controls arc used for monitoring the performance of the ARCHITECT i System when used for the qualitative detection of IgG and IgM antibodies to hepatitis B core antigen (anti-HBc) with the ARCHITECT CORE Reagent Kit. The performance of the ARCHITECT CORE Controls has not been established with any other anti-HBc assays. |
PMA Supplemental Approvals
| APPLICATION NUMBER / DATE of APPROVAL | DEVICE TRADE NAME | COMPANY NAME CITY, STATE, & ZIP | DEVICE DESCRIPTION / INDICATIONS |
|---|---|---|---|
| P810002/S069 4/23/09 180-Day |
SJM Masters HP™ Valved Graft with Gelweave Valsalva Technology | St. Jude Medical St. Paul , MN 5117 |
Approval for a sterilization site located at Steris Isomedix Services, Minneapolis, Minnesota for Ethylene Oxide (ETO) Sterilization. |
| P810046/S228 4/6/09 135-Day |
Voyager™ RX Coronary Dilatation Catheter | Abbott Vascular, Inc. Temecula , CA 92591 |
Approval to re-establish the Temecula, California manufacturing site for the device. |
| P830061/S046 4/28/09 Real-Time |
CapSure Sense Lead | Medtronic, Inc. Cardiac Rhythm Disease Management Mounds View, MN 55112 |
Approval for a new kit containing individually packaged lead anchoring sleeves. The kit will be marketed under the trade name Model 5867 AS Anchoring Sleeve Kit and is intended for use with the Medtronic implantable endocardial lead families listed. |
| P840001/S128 4/1/09 Real-Time |
Restore PRIME, PrimeADVANCED, Restore Rechargeable, RestoreADVANCED Rechargeable | Medtronic, Inc. Minneapolis , MN 55432 |
Approval for redesign of the 6-pin Filtered Feedthrough. |
| P840001/S131 4/20/09 Real-Time |
Restore PRIME, PrimeADVANCED, Restore Rechargeable, RestoreULTRA, RestoreAD-VANCED Rechargeable | Medtronic, Inc. Minneapolis , MN 55432 |
Approval for Model 74001 (1x4) Pocket Adaptor and Model 74002 (2x4) Pocket Adaptor. |
| P860019/S230 4/13/09 Real-Time |
Maverick Over-the-Wire (OTW), Quantum Maverick OTW | Boston Scientific Corporation Maple Grove , MN 55311 |
Approval for a change to the bond length specification limits for the catheter manufacturing process. |
| P870072/S041 4/24/09 180-Day |
Thoratec Implantable Ventricular Assist Device (IVAD) System | Thoratec Corporation Pleasanton , CA 94588 |
Approval to modify the labeling to include post-approval study information for the IVAD system. |
| P890003/S166 4/24/09 Real-Time |
Consulta, Concerto II, Maximo II CRT-D and Secura, Virtuoso II, Maximo II ICDs, InSync III, RV Lead Integrity Alert |
Medtronic, Inc. Cardiac Rhythm Disease Management Mounds View, MN 55112 |
Approval for additional changes to support migration from OS/2 to XPe. |
| P900007/S005 4/2/09 Real-Time |
Cook® Chorionic Villus Sampling Set | Cook Urological, Inc. Cook Ob/Gyn Spencer , IN 74760 |
Approval for the addition of Echotip® banding to the distal two centimeters of the obturator. |
| P900052/S016 4/20/09 Real-Time |
PORT-A-CATH Epidural and PORT-A CATH II Epidural Low Profile Implantable Access Systems |
Smiths Medical MD, Inc. St. Paul , MN 55112 |
Approval for a label claim “does not contain natural rubber latex.” |
| P910023/S201 4/8/09 Real-Time |
Cadence Family of ICDs | St. Jude Medical Cardiac Rhythm Management Division Sunnyvale , CA 94086 |
Approval for Current/Current+ and Promote/Promote+ devices including Current- DR CD2211-36Q, Current+ VR CD1211-36Q, Promote + CD3211-36Q, Current VR CD1207-36Q, Current DR 2207-36Q, and Promote CD3207-36Q. Additionally, you requested approval to include the devices within an ongoing post approval study, pending final approval by the Office of Surveillance and Biometrics. That post-approval study is being conducted as a condition of approval for P950022/S042, P030054/S067, and P910023/S154. |
| P910023/S203 4/14/09 Real-Time |
Cadence Family of ICDs | St. Jude Medical Cardiac Rhythm Management Division Sunnyvale , CA 94086 |
Approval for modifications to the high voltage capacitors for Atlas, +/II, Current and Promote, RF/+ HE (36 J) and Epic, +/II Current and Promote, RF/+ SE (30 J) families of ICD/CRT-D devices. |
| P910023/S204 4/16/09 Real-Time |
Current/Current + DR | St. Jude Medical Cardiac Rhythm Management Division Sunnyvale , CA 94086 |
Approval to extend the shelf life of the device. |
| P910023/S207 4/30/09 Real-Time |
Cadence Family of ICDs | St. Jude Medical Cardiac Rhythm Management Division Sunnyvale , CA 94086 |
Approval for enhancements to the software (version 4.0) used in the St. Jude Medical Merlin.net system. |
| P910023/S208 4/28/09 Real-Time |
Cadence Family of ICDs | St. Jude Medical Cardiac Rhythm Management Division Sunnyvale , CA 94086 |
Approval for the Model EX2000 V.4.0 version software for use on the St. Jude Medical Merlin@home devices. |
| P910077/S092 4/28/09 Real-Time |
Latitude Inductive Communicator | Boston Scientific CRM St. Paul , MN 55112 |
Approval for software changes to the Latitude Patient Management System Inductive Communicator Model 6481, version 1.5. |
| P910077/S093 4/28/09 Real-Time |
Latitude Inductive Communicator | Boston Scientific CRM St. Paul , MN 55112 |
Approval for changes to the Latitude Patient Management System Inductive Communicator Model 6481, version 1.5. |
| P920015/S053 4/28/09 Real-Time |
Sprint Quattro Family of Leads | Medtronic, Inc. Cardiac Rhythm Disease Management Mounds View, MN 55112 |
Approval for a new kit containing individually packaged lead anchoring sleeves. The kit will be marketed under the trade name Model 5867 AS Anchoring Sleeve Kit and is intended for use with the Medtronic implantable endocardial lead families listed. |
| P930039/S031 4/28/09 Real-Time |
CapSure SP Novus Lead | Medtronic, Inc. Cardiac Rhythm Disease Management Mounds View, MN 55112 |
Approval for a new kit containing individually packaged lead anchoring sleeves. The kit will be marketed under the trade name Model 5867 AS Anchoring Sleeve Kit and is intended for use with the Medtronic implantable endocardial lead families listed. |
| P940015/S013 4/10/09 135-Day |
Synvisc® | Genzyme Corporation Cambridge , MA 02142 |
Approval for the relocation of manufacturing processes within the same facility and the addition of an alternate syringe filling machine. |
| P940016/S011 4/20/09 Real-Time |
Plasmat® Secura Heparin-Induced Extracorporeal LDL Apheresis (H.E.L.P.) System | B. Braun Medical, Inc. Allentown , PA 18109 |
Approval for an extension of shelf-life from 5 years to 6 years for the precipitate filter component of the device. |
| P940016/S012 4/20/09 Real-Time |
Plasmat® Secura Heparin-Induced Extracorporeal LDL Apheresis (H.E.L.P.) System | B. Braun Medical, Inc. Allentown , PA 18109 |
Approval for a change to the packaging material in the pouch used for the heparin adsorber component of the device. |
| P950020/S032 4/13/09 180-Day |
Coronary Flextome Cutting Balloon Device | Boston Scientific Corporation San Diego , CA 92121 |
Approval for a sterilization site located at Isotron Plc, Daventry, United Kingdom for radiation sterilization. |
| P950029/S042 4/2/09 Special |
Reply DR and Reply SR | ELA Medical, Inc. Plymouth , MN 55441 |
Approval for labeling changes to the Reply DR and Reply SR implant manuals. |
| P950037/S071 4/16/09 Real-Time |
CardioMessenger II-S (TLine) Software Version 1.20, CardioMessenger LLT, CardioMessenger TLine; CardioMessenger II | Biotronik, Inc. Lake Oswego , OR 97035 |
Approval for the removal of the dial-in prefixes in the device. |
| P960009/S052 4/7/09 180-Day |
Activa PC Implantable Neurostimulation System | Medtronic, Inc. Minneapolis , MN 55432 |
Approval for new Activa PC Implantable Neurostimulation System (INS), intended for Deep Brain Stimulation (DBS). The device, as modified, will be marketed under the trade name Activa PC and is indicated for the following: Parkinson's Control Therapy Bilateral stimulation of the internal globus pallidus (GPi) or the subthalamic nucleus (STN) using Medtronic Activa Parkinson's Control Therapy is indicated for adjunctive therapy in reducing some of the symptoms of advanced, levodoparesponsive Parkinson's disease that are not adequately controlled with medication. Tremor Control Therapy Unilateral thalamic stimulation by the Medtronic Activa Tremor Control System is indicated for the suppression of tremor in the upper extremity. The system is intended for use in patients who are diagnosed with Essential Tremor or Parkinsonian tremor not adequately controlled by medications and where the tremor constitutes a significant functional disability. |
| P960013/S045 4/16/09 Special |
Tendril ST Model 1888 | St. Jude Medical Cardiac Rhythm Management Division Sylmar , CA 91342 |
Approval for minor labeling changes that enhance instructions for safe device use in the Tendril ST Model 1888 User’s Manual. |
| P960040/S192 4/28/09 Real-Time |
Prizm and Vitality Families | Boston Scientific CRM St. Paul , MN 55112 |
Approval for changes to the Latitude Patient Management System Inductive Communicator Model 6481, version 1.5. |
| P970004/S064 4/30/09 180-Day |
Medtronic InterStim® Therapy for Urinary Control | Medtronic Neuromodulation Minneapolis , MN 55432 |
Approval for clarifying labeling modifications and extension of the tined lead test implantation to 14 days. |
| P970012/S039 4/21/09 135-Day |
Kappa 400 DR; Kappa 400 SR | Medtronic, Inc. Mounds View, MN 55126 |
Approval of the addition of an ethylene oxide sterilizer. |
| P970021/S026 4/28/09 Real-Time |
Gynecare Thermachoice® III Uterine Balloon Therapy (UBT) System | Ethicon, Inc. – Women’s Health and Urology Somerville , NJ 08876 |
Approval for revised patient labeling. |
| P970037/S002 4/8/09 180-Day |
AutoDELFIA® hAFP Kit | Perkin Elmer, Inc. Indianapolis , IN 46236 |
Approval for a change in the production site or the two antibodies used in the AutoDELIA® hAFP kit to Wallac Oy, Turk, Finland, and for a change in the antigen source in the hAFP standards of the AutoDELIA® hAFP kit. |
| P980016/S146 4/21/09 135-Day |
GEM II Family; Marquis Family; Maximo Family; Intrinsic Family; EnTrust Family; Virtuoso Family; Maximo Family; Secura Family | Medtronic, Inc. Mounds View, MN 55126 |
Approval of the addition of an ethylene oxide sterilizer. |
| P980016/S166 4/1/09 135-Day |
Secura ICD, Maximo II ICD, Virtuoso II DR, and Virtuoso II VR | Medtronic, Inc. Cardiac Rhythm Disease Management Mounds View, MN 55112 |
Approval of the hybrid final functional testing. |
| P980016/S168 4/16/09 135-Day |
Virtuoso ICD | Medtronic, Inc. Mounds View, MN 55112 |
Approval for modifications to the hybrid test used on multiple implantable devices. |
| P980016/S170 4/27/09 135-Day |
Secura Maximo II, Virtuoso DR/VR II Family of Implantable Cardioverter Defibrillators (ICDs) | Medtronic, Inc. Cardiac Rhythm Disease Management Mounds View, MN 55112 |
Approval for modifications to the hybrid test software. |
| P980016/S183 4/24/09 Real-Time |
Consulta, Concerto II, Maximo II CRT-D and Secura, Virtuoso II, Maximo II ICDs, InSync III, RV Lead Integrity Alert |
Medtronic, Inc. Cardiac Rhythm Disease Management Mounds View, MN 55112 |
Approval for additional changes to support migration from OS/2 to XPe. |
| P980022/S047 4/6/09 Real-Time |
CGMS iPro Continuous Glucose Monitoring System | Medtronic MiniMed Northridge , CA 91325 |
Approval for a modification to the Solutions Software for the CGMS iPro Continuous Glucose Recorder (MMT-7319) to add an auto detect feature to allow the software to automatically recognize the computer’s active ports and to correct previously identified anomalies. |
| P980022/S048 4/9/09 Real-Time |
Medtronic MiniMed Continuous Glucose Monitoring System, SOF-SENSORS on Phillips Base Models MMT-7002, MMT-7003 | Medtronic MiniMed Northridge , CA 91325 |
Approval for design changes to the MMT-7002 and MMT-7003 glucose sensors models and a new supplier qualification. The design changes included an increase of the needle tunnel height and base from 0.034" to 0.036" and 0.030" and 0.031", respectively. These changes were intended to reduce the probability of a user having difficulty with removing the needle after sensor insertion. Further, the connector ledge of the senor base was increased from 0.007" to 0.011" to reduce relative rotational motion between the sensor base connector and GST transmitter. Phillips Plastics was also qualified as a new supplier for the glucose sensor bases in this supplement. The qualification included modifications including modifications to the needle guard core pin, a manufacturing tooling device. This device is intended to continuously record interstitial glucose levels in persons with diabetes mellitus. This information is intended to supplement, not replace, blood glucose information obtained using a standard home glucose-monitoring devices. This information may allow identification of patterns of glucose level excursions above or below the desired range, facilitating therapy adjustments which may minimize these excursions. |
| P980035/S108 4/21/09 135-Day |
Kappa 600/700, 650, 800/900 Family; Sigma Family; Medtronic 350 Series; EnPulse II Family; EnRhythm IPG; AT501 System; Adapta/Versa/ Sensia Family | Medtronic, Inc. Mounds View, MN 55126 |
Approval of the addition of an ethylene oxide sterilizer. |
| P980043/S018 4/8/09 Real-Time |
Hancock® II Bioprosthesis | Medtronic Heart Valves Santa Ana , CA 92705 |
Approval for modifications to the Cinch® Valve Holder Documents. |
| P990001/S040 4/21/09 135-Day |
Dema Family (includes Clarity DDDR, Clarity SSIR, Diamond III, Ruby III, Topaz III, Jade III, Vita 2 DDDR); C-series Devices; T-series Devices. |
Medtronic, Inc. Mounds View, MN 55126 |
Approval of the addition of an ethylene oxide sterilizer. |
| P990013/S018 4/2/09 180-Day |
STAAR Surgical Collamer UV-Absorbing PC Intraocular Lens (IOL) | STAAR Surgical Company Monrovia , CA 91016 |
Approval for a change in stopper material for the device. |
| P990046/S019 4/24/09 180-Day |
Open Pivot Bi-leaflet Heart Valve |
ATS Medical, Inc. Minneapolis , MN 55447 |
Approval of the post-approval study protocol. |
| P990064/S026 4/8/09 Real-Time |
Mosaic® Porcine Bioprosthesis | Medtronic Heart Valves Santa Ana , CA 92705 |
Approval for modifications to the Cinch® Valve Holder Documents. |
| P000020/S012 4/21/09 Real-Time |
Stinger, Stinger S, Scorpion, Scorpion *2 Ablation Catheters and TempLink Extension Cables | C.R. Bard, Inc. Lowell , MA 01851 |
Approval for use of the Stinger, Stinger S, Scorpion, Scorpion *2 ablation catheters with the Boston Scientific Maestro 3000, EPT-1000XP, and Irvine Biomedical IBI-1500 T9 and IBI-150 T6 RF generators. |
| P000025/S039 4/30/09 Real-Time |
Med-El Cochlear Implant System | Med-El Corporation Durham , NC 27713 |
Approval for changes made to the following user manuals: DIB II (Diagnostic Interface Box), OPUS 1, OPUS 2 and TEMPO+ Speech Processors, RBP (Remote Battery Pack) and Microphone test Device (MTD). |
| P000029/S042 4/1/09 135-Day |
Deflux® Injectable Gel | Q-Med Scandinavia, Inc. Princeton , NJ 08540 |
Approval for upgraded processing equipment and change in the storage temperature of the raw material. |
| P000039/S029 4/8/09 Real-Time |
Amplatzer Septal Occluder and Multi-fenestrated (cribriform) Septal Occluder | AGA Medical Corporation Plymouth , MN 55442 |
Approval for modification in packaging materials and the use of a new sealer to accommodate the new packaging materials. |
| P010012/S205 4/28/09 Real-Time |
Contak and Renewal Families | Boston Scientific CRM St. Paul , MN 55112 |
Approval for changes to the Latitude Patient Management System Inductive Communicator Model 6481, version 1.5. |
| P010015/S049 4/21/09 135-Day |
InSync Pulse Generator; InSync III | Medtronic, Inc. Mounds View, MN 55126 |
Approval of the addition of an ethylene oxide sterilizer. |
| P010015/S064 4/24/09 Real-Time |
Consulta, Concerto II, Maximo II CRT-D and Secura, Virtuoso II, Maximo II ICDs, InSync III, RV Lead Integrity Alert |
Medtronic, Inc. Cardiac Rhythm Disease Management Mounds View, MN 55112 |
Approval for additional changes to support migration from OS/2 to XPe. |
| P010015/S067 4/28/09 Real-Time |
Attain OTW Lead | Medtronic, Inc. Cardiac Rhythm Disease Management Mounds View, MN 55112 |
Approval for a new kit containing individually packaged lead anchoring sleeves. The kit will be marketed under the trade name Model 5867 AS Anchoring Sleeve Kit and is intended for use with the Medtronic implantable endocardial lead families listed. |
| P010031/S115 4/21/09 135-Day |
InSync ICD; InSync Marquis; InSync II Marquis Family; InSync III Marquis Family; InSync II Protect; InSync III Protect; InSync Sentry Family; InSync Maximo Family; Concerto; Maximo II: Consulta CRT-D |
Medtronic, Inc. Mounds View, MN 55126 |
Approval of the addition of an ethylene oxide sterilizer. |
| P010031/S133 4/1/09 135-Day |
Consulta CRT-D, Maximo II CRT-D, and Concerto II CRT-D | Medtronic, Inc. Cardiac Rhythm Disease Management Mounds View, MN 55112 |
Approval of the hybrid final functional testing. |
| P010031/S135 4/16/09 135-Day |
Concerto CRT-D | Medtronic, Inc. Mounds View, MN 55112 |
Approval for modifications to the hybrid test used on multiple implantable devices. |
| P010031/S137 4/27/09 135-Day |
Consulta, Maximo II, Concerto II Family of Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) |
Medtronic, Inc. Cardiac Rhythm Disease Management Mounds View, MN 55112 |
Approval for modifications to the hybrid test software. |
| P010031/S146 4/24/09 Real-Time |
Consulta, Concerto II, Maximo II CRT-D and Secura, Virtuoso II, Maximo II ICDs, InSync III, RV Lead Integrity Alert |
Medtronic, Inc. Cardiac Rhythm Disease Management Mounds View, MN 55112 |
Approval for additional changes to support migration from OS/2 to XPe. |
| P020004/S040 4/8/09 180-Day |
Gore Excluder AAA Endoprosthesis | W.L. Gore & Associates, Inc. Flagstaff , AZ 86003 |
Approval for the distribution of the 2008 Annual Clinical Update to Physician Users for the device. |
| P020009/S048 4/13/09 Real-Time |
Express 2 OTW | Boston Scientific Corporation Maple Grove , MN 55311 |
Approval for a change to the bond length specification limits for the catheter manufacturing process. |
| P020014/S022 4/20/09 180-Day |
Conceptus Essure® System for Permanent Birth Control | Conceptus, Inc. Mountain View , CA 94041 |
Approval for changes to the physician labeling precaution regarding magnetic resonance imaging of women with Essure® micro-inserts. |
| P020018/S032 4/2/09 180-Day |
Zenith Flex® AAA Endovascular Graft | Cook Inc. Bloomington , IN 47402 |
Approval for modifications to the top cap trigger wire, delivery system positioner, and trigger knob set screw. |
| P020022/S007 4/14/09 Real-Time |
Versant 440 Molecular System and Versant HCV RNA 3.0 Assay (bDNA) | Siemens Healthcare Diagnostics Berkeley , CA 94710 |
Approval for software changes to the 440 System Software and DMS Software (Release 3). |
| P020024/S023 4/8/09 Real-Time |
Amplatzer Duct Occluder | AGA Medical Corporation Plymouth , MN 55442 |
Approval for modification in packaging materials and the use of a new sealer to accommodate the new packaging materials. |
| P020056/S009 4/22/09 180-Day |
Natrelle® Silicone Filled Breast Implants | Allergan Goleta , CA 93117 |
Approval for labeling that reflects the focus group study findings and 7-year Core Study data. |
| P030016/S006 4/2/09 180-Day |
STAAR Visian Implantable Collamer Lens | STAAR Surgical Company Monrovia , CA 91016 |
Approval for a change in stopper material for the Collamer Lens. |
| P030017/S075 4/3/09 135-Day |
Precision® Spinal Cord Stimulator System | Boston Scientific Neuromodulation Corporation Sylmar , CA 91342 |
Approval for the modification to the lead HiPot test. |
| P030017/S083 4/2/09 135-Day |
Precision® Spinal Cord Stimulator System | Boston Scientific Neuromodulation Corporation Sylmar , CA 91342 |
Approval for the modification to the contact welding for the lead extension. |
| P030025/S060 4/13/09 Real-Time |
TAXUS™ Express 2 OTW | Boston Scientific Corporation Maple Grove , MN 55311 |
Approval for a change to the bond length specification limits for the catheter manufacturing process. |
| P030029/S005 4/9/09 180-Day |
ADVIA Centaur anti-HBs Ready Pack Reagents and Calibrator, ADVIA Centaur anti-HBs Control Material |
Siemens Healthcare Diagnostics, Inc. Walpole , MA 02032 |
Approval for adding ADVIA Centaur XP instrument to the intended use of the approved device ADVIA Centaur anti-HBs Ready Pack Reagents and Calibrators. The device, as modified, will be marketed under the trade name ADVIA Centaur's) and ADVIA Centaur® XP anti-HBs Assay and is indicated for: ADVIA Centaur anti-HBs Ready Pack Reagents and Calibrator: 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 and ADVIA Centaur XP Systems. 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 results will allow a differential diagnosis in individuals displaying signs and symptoms of hepatitis in whom etiology is unknown. ADVIA Centaur anti-HBs Control Material: For monitoring the performance of the Anti-HBs assay on the ADVIA Centaur and ADVIA Centaur XP systems. |
| P030036/S013 4/28/09 Real-Time |
Select Secure Lead | Medtronic, Inc. Cardiac Rhythm Disease Management Mounds View, MN 55112 |
Approval for a new kit containing individually packaged lead anchoring sleeves. The kit will be marketed under the trade name Model 5867 AS Anchoring Sleeve Kit and is intended for use with the Medtronic implantable endocardial lead families listed. |
| P030040/S004 4/9/09 180-Day |
ADVIA Centaur® HBc IgM ReadyPack Reagents and ADVIA Centaur® HBc IgM Quality Control Materials | Siemens Healthcare Diagnostic, Inc. Tarrytown , NY 10591 |
Approval for adding ADVIA Centaur XP instrument to the intended use of the approved device ADVIA Centaur HBc IgM Assay. The device, as modified, will be marketed under the trade name ADVIA Centaur® HBc IgM Assay and is indicated for: The ADVIA Centaur HBc IgM assay is an in vitro diagnostic test for the qualitative determination of IgM response to hepatitis B virus core antigen in human serum and plasma (EDTA or lithium or sodium heparinized) using the ADVIA Centaur and ADVIA Centaur XP Systems. The assay uses recombinant HBc antigen. This assay may be used in combination with other hepatitis B virus (HBV) marker assays to define the clinical status of known HBV infected patients or can be combined with other HBV. HAV (hepatitis A virus), and HCV (hepatitis C virus) assays for the diagnosis of patients presenting symptoms of acute viral hepatitis. Assay performance characteristics have not been established for immunocompro-mised or immunosuppressed patients, cord blood, neonatal specimens, infants, or children. Assay performance characteristics have not been established when the ADVIA Centaur HBc IgM assay is used in conjunction with other manufacturers' assays for specific HBV serological markers. |
| P030049/S004 4/9/09 180-Day |
AVIA Centaur HBsAg ReadyPack Reagents, AVIA Centaur HBsAg ReadyPack Confirmatory Assay, and AVIA Centaur HBsAg Quality Control Material | Siemens Healthcare Diagnostic, Inc. Tarrytown , NY 10591 |
Approval for adding ADVIA Centaur XP instrument to the intended use of the approved devices ADVIA Centaur HBsAg and ADVIA HBsAg Confirmatory Assay. The devices, as modified, will be marketed under the trade name ADVIA Centaur HBsAg ReadyPack Reagents. ADVIA Centaur HBsAg ReadyPack Confirmatory Assay and ADVIA Centaur HBsAg Quality Control Material are indicated for: ADVIA Centaur HBsAg ReadyPack Reagents 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 heparin) using the ADVIA Centaur and ADVIA Centaur XP systems. The assay may be used in conjunction with other serological and clinical information to diagnose individuals with acute or chronic hepatitis B infection. This product is not for use for testing or screening pooled samples containing specimens from more than one individual, or otherwise in blood or plasma screening. ADVIA Centaur HBsAg ReadyPack Confirmatory Assay: 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 and ADVIA Centaur XP systems. The assay is intended to be used to confirm the presence of HBsAg in samples that are repeatedly reactive using the ADVIA Centaur Assay. ADVIA Centaur HBsAg Quality Control Material: For monitoring the performance of the HBsAg and HBsAg Confirmatory assays on the ADVIA Centaur Systems when using serum. |
| P030054/S117 4/8/09 Real-Time |
Epic HF/Atlas+ Family of CRT-Ds | St. Jude Medical Cardiac Rhythm Management Division Sunnyvale , CA 94086 |
Approval for Current/Current+ and Promote/Promote+ devices including Current- DR CD2211-36Q, Current+ VR CD1211-36Q, Promote + CD3211-36Q, Current VR CD1207-36Q, Current DR 2207-36Q, and Promote CD3207-36Q. Additionally, you requested approval to include the devices within an ongoing post approval study, pending final approval by the Office of Surveillance and Biometrics. That post-approval study is being conducted as a condition of approval for P950022/S042, P030054/S067, and P910023/S154. |
| P030054/S119 4/14/09 Real-Time |
Epic HF/Atlas+ Family of CRT-Ds | St. Jude Medical Cardiac Rhythm Management Division Sunnyvale , CA 94086 |
Approval for modifications to the high voltage capacitors for Atlas, +/II, Current and Promote, RF/+ HE (36 J) and Epic, +/II Current and Promote, RF/+ SE (30 J) families of ICD/CRT-D devices. |
| P030054/S120 4/16/09 Real-Time |
Promote/Promote + CRT-D | St. Jude Medical Cardiac Rhythm Management Division Sunnyvale , CA 94086 |
Approval to extend the shelf life of the device. |
| P030054/S123 4/28/09 Real-Time |
Epic HF/Atlas+ Family of CRT-Ds | St. Jude Medical Cardiac Rhythm Management Division Sunnyvale , CA 94086 |
Approval for the Model EX2000 V.4.0 version software for use on the St. Jude Medical Merlin@home devices. |
| P030056/S004 4/9/09 180-Day |
ADVIA Centaur HCV ReadyPack Reagents and ADVIA Centaur HCV Quality Control Materials | Siemens Healthcare Diagnostics, Inc. Tarrytown , NY 10591 |
Approval for adding ADVIA Centaur XP instrument to the intended use of the approved device ADVIA Centaur HCV Assay. The device, as modified, will be marketed under the trade name ADVIA Centaur HCV Assay and is indicated for: ADVIA Centaur HCV Assay: 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 heparin) using the ADVIA Centaur and ADVIA Centaur XP systems. 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: For in vitro diagnostic use in monitoring the performance of the HCV assay on the ADVIA Centaur systems. The performance of the HCV quality control material has not been established with any other anti-HCV assays. |
| P040002/S022 4/17/09 180-Day |
Powerlink System, 25mm, and 28mm Suprarenal Cuff Accessories for the Infrarenal Version of the PowerLink Bifurcated Stent Graft | Endologix, Inc. Irvine , CA 92618 |
Approval for the 25mm and 28mm suprarenal cuff accessories for the infrarenal version of the Powerlink bifurcated stent graft. |
| P040004/S004 4/9/09 180-Day |
ADVIA Centaur® HBc Total ReadyPack Reagents and ADVIA Centaur® HBc Total Quality Control Materials | Siemens Healthcare Diagnostics, Inc. Tarrytown , NY 10591 |
Approval for adding ADVIA Centaur XP instrument to the intended use of the approved device ADVIA Centaur HBc Total Assay. The device, as modified, will be marketed under the trade name ADVIA Centaur® HBc Total Assay and is indicated for: The ADVIA Centaur HBc Total assay is an in vitro diagnostic test for the qualitative determination of total antibodies to the core antigen of the hepatitis B virus (HBc Total) in human serum or plasma (potassium EDTA, or lithium or sodium heparinized) using the ADVIA Centaur and ADVIA Centaur XP Systems. This assay can be used as an aid in the diagnosis of individuals with acute or chronic hepatitis B virus (HBV) infection and in the determination of the clinical status of HBV infected individuals in conjunction with other HBV serological markers for the laboratory diagnosis of HBV disease associated with HBV infection. This assay can also be used as an aid in the differential diagnosis in individuals displaying signs and symptoms of hepatitis in whom etiology is unknown. |
| P040016/S034 4/13/09 Real-Time |
Liberté OTW | Boston Scientific Corporation Maple Grove , MN 55311 |
Approval for a change to the bond length specification limits for the catheter manufacturing process. |
| P040025/S007 4/22/09 180-Day |
Olympic Cool-Cap System | Natus Medical, Inc. Seattle , WA 98108 |
Approval for design changes associated with software upgrade from Cool-Cap 1.0 to Cool-Cap 1.1, as well as associated labeling changes. |
| P040040/S009 4/8/09 Real-Time |
Amplatzer Muscular VSD Occluder | AGA Medical Corporation Plymouth , MN 55442 |
Approval for modification in packaging materials and the use of a new sealer to accommodate the new packaging materials. |
| P040044/S011 4/8/09 Real-Time |
M5 Mynx® Vascular Closure Device | Access Closure, Inc. Mountain View , CA 94043 |
Approval for minor design changes to the 6F/7F Mynx® Vascular Closure Device. The device, as modified, will be marketed under the trade name M5 Mynx® Vascular Closure Device and is indicated for use to seal femoral arterial access sites while reducing times to hemostasis and ambulation in patients who have undergone diagnostic or interventional endovascular procedures utilizing a 5F procedural sheath. |
| P040044/S012 4/15/09 Special |
Mynx® Vascular Closure Device | Access Closure, Inc. Mountain View , CA 94043 |
Approval for modifying the instructions for use to include the use of 50% contrast media / 50% saline solution for inflating the balloon catheter. |
| P050006/S011 4/24/09 135-Day |
Gore Helex Septal Occluder | W.L. Gore & Associates, Inc. Flagstaff , AZ 86001 |
Approval to remove a Quality Control Test from the manufacturing process for the device. |
| P050009/S004 4/17/09 135-Day |
C2A Acetabular System | Biomet, Inc. Warsaw , IN 46581 |
Approval for a change in the material of the inner pouch which holds the sterile porous hip cups, including components of the device. |
| P050020/S011 4/13/09 180-Day |
FreeStyle Navigator Continuous Glucose Monitoring System | Abbott Diabetes Care Alameda , CA 94502 |
Approval for a sterilization site located at Nutek Corporation, Hayward, California, to perform sterilization of the Sensor Delivery Unit. |
| P050020/S013 4/9/09 Real-Time |
FreeStyle Navigator Continuous Glucose Monitoring System, CoPilot Health Management System for FreeStyle Naviator | Abbott Diabetes Care Alameda , CA 94502 |
Approval for an updated version of the CoPilot Health Management System for FreeStyle Navigator Labeling and help files in the application to add windows Vista as an operating system that the application can be installed on as well as adding the necessary steps to allow the application and device to be used with Vista. |
| P050023/S023 4/16/09 Real-Time |
CardioMessenger II-S (TLine) Software Version 1.20, CardioMessenger LLT, CardioMessenger TLine; CardioMessenger II | Biotronik, Inc. Lake Oswego , OR 97035 |
Approval for the removal of the dial-in prefixes in the device. |
| P060008/S004 4/13/09 Real-Time |
TAXUS™ Liberté OTW | Boston Scientific Corporation Maple Grove , MN 55311 |
Approval for a change to the bond length specification limits for the catheter manufacturing process. |
| P070007/S009 4/22/09 Special |
Talent™ Thoracic Stent Graft System | Medtronic Vascular Santa Rosa , CA 95403 |
Approval for modifications to the labeling. |
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 |
|---|---|---|---|
| N17600/S024 4/17/09 |
Avitene® Microfibrillar Collagen Hemostat (MCH) Family, Avitene® Microfibrillar Collagen Hemostat (MCH) Flour, Avitene® Microfibrillar Collagen Hemostat (MCH) Non-Woven Web, Avitene® UltraFoam® Cast Microfibrillar Collagen Hemostat (MCH) Sponge, Avitene® Microfibrillar Collagen Hemostat (MCH) UltraWrap®, Avitene® Microfibrillar Collagen Hemostat (MCH) EndoAvitene®, Avitene® Microfibrillar Collagen Hemostat (MCH) SyringeAvitene™ |
Davol, Inc. Warwick , RI 02886 |
Changes in the sterilization validation method. |
| P800002/S016 4/17/09 |
Avitene® Microfibrillar Collagen Hemostat (MCH) Family, Avitene® Microfibrillar Collagen Hemostat (MCH) Flour, Avitene® Microfibrillar Collagen Hemostat (MCH) Non-Woven Web, Avitene® UltraFoam® Cast Microfibrillar Collagen Hemostat (MCH) Sponge, Avitene® Microfibrillar Collagen Hemostat (MCH) UltraWrap®, Avitene® Microfibrillar Collagen Hemostat (MCH) EndoAvitene®, Avitene® Microfibrillar Collagen Hemostat (MCH) SyringeAvitene™ |
Davol, Inc. Warwick , RI 02886 |
Changes in the sterilization validation method. |
| P810002/S070 4/30/09 |
St. Jude Masters Valved Graft | St. Jude Medical Cardiovascular Division St. Paul , MN 55117 |
Change to the method of radiation sterilization dose audits. |
| P810046/S229 4/24/09 |
POWERSAIL® Coronary Dilation Catheter | Abbott Vascular, Inc. Temecula , CA 92591 |
Addition of visual inspection of the distal shaft and the addition of a verification of in-process measuring equipment. |
| P840001/S133 4/8/09 |
Restore ULTRA Implantable Neurostimulators | Medtronic Neuromodulation Minneapolis , MN 55432 |
Addition of a header rework process for the device. |
| P840001/S137 4/30/09 |
Restore Family of Implantable Neurostimulators | Medtronic Neuromodulation Minneapolis , MN 55432 |
Change to automate a manufacturing process and the addition of visual inspections during the process. |
| P850079/S045 4/15/09 |
Frequency 55 UV (methafilcon A) Soft Contact Lens for Extended Wear | CooperVision, Inc. Norfolk , VA 23507 |
Addition of an alternate qualified supplier of a raw material use in the manufacturing of methafilcon A soft contact lenses. |
| P860004/S106 4/16/09 |
SynchroMed II Infusion System | Medtronic Neuromodulation Minneapolis , MN 55432 |
Modification to the method for transferring test data from the Over Pressure Mechanism In-process Test into FACTORY works. |
| P860019/S233 4/8/09 |
Quantum Maverick and Maverick 2 PTCA Catheters | Boston Scientific Corporation Maple Grove , MN 55311 |
Change from a semi-automated in-process inspection of the Guide Wire Port Bond to an automated in-process inspection. |
| P870024/S046 4/29/09 |
Paragon Rigid Gas Permeable Contact Lens (paflufocon C®) and Paragon Rigid Gas Permeable Contact Lens (paflufocon B®) | Paragon Vision Sciences Mesa , AZ 85204 |
Change in the manufacturing materials. |
| P910023/S205 4/28/09 |
Current / Current+ ICD |
St. Jude Medical Cardiac Rhythm Management Division Sylmar , CA 91342 |
Addition of a flex circuit supplier. |
| P930038/S057 4/8/09 |
Angio-Seal™ Vascular Closure Device | St. Jude Medical, Inc. Maple Grove , MN 55311 |
Alternative lot release moisture specification assurance method. |
| P950029/S043 4/2/09 |
Symphony SR and DR Pacemaker, Rhapsody SR and DR Pacemaker, Reply SR and DR Pacemaker | ELA Medical, Inc./ Sorin Group Plymouth , MN 55441 |
Change in the drying method for the hybrid module. |
| P950037/S070 4/3/09 |
CardioMessenger EDP 30, ICS 3000 | Biotronik, Inc. Lake Oswego , OR 97035 |
Change in manufacturing location for external devices to another location in Berlin, Germany. |
| P960009/S066 4/30/09 |
Activa RC and Activa PC Implantable Neurostimulators | Medtronic Neuromodulation Minneapolis , MN 55432 |
Change to automate a manufacturing process and the addition of visual inspections during the process. |
| P970004/S072 4/30/09 |
Interstim II Implantable Neurostimulators | Medtronic Neuromodulation Minneapolis , MN 55432 |
Change to automate a manufacturing process and the addition of visual inspections during the process. |
| P970012/S054 4/3/09 |
Kappa 400 DR IPG, Kappa 400 SR IPG | Medtronic, Inc. Mounds View, MN 55112 |
Addition of a new barb welding system. |
| D970012/S064 4/7/09 |
AMS 700™ Series Inflatable Penile Prosthesis | American Medical Systems Minnetonka , MN 55343 |
Implementation of a coating process at American Medical Systems, Inc. as an alternate manufacturing site and to implement a conveyor oven as an alternate heating source. |
| P980016/S185 4/2/09 |
Virtuoso ICD | Medtronic, Inc. Mounds View, MN 55112 |
Modification of the incoming visual inspection sampling plan. |
| P980016/S186 4/3/09 |
EnTrust, Virtuoso, Virtuoso II DR/VR, Secura DR/VR, Maximo II DR/VR | Medtronic, Inc. Mounds View, MN 55112 |
Automate the manufacturing process for the insert-molded bond pad array component. |
| P980016/S188 4/15/09 |
Virtuoso ICD, Virtuoso II ICD, Secura ICD, Maximo II ICD | Medtronic, Inc. Mounds View, MN 55112 |
Changes to the hybrid and final test for the device. |
| P980016/S189 4/22/09 |
EnTrust ICDs, Virtuoso ICDs, Maximo II ICDs, Secura ICDs, Marquis ICDs, Maximo ICDs, Intrinsic 350J ICD, Intrinsic 30, Virtuoso II ICDs | Medtronic, Inc. Mounds View, MN 55112 |
Change in manufacturing process for capacitor. |
| P980016/S192 4/24/09 |
Maximo VR, Maximo DR, Marquis VR, Marquis DR, Intrinsic, Virtuoso, Entrust, Secura, Maximo II DR/VR | Medtronic, Inc. Mounds View, MN 55112 |
Change in the type of curing oven. |
| P980022/S049 4/2/09 |
Paradigm Real-Time Insulin Pump | Medtronic MiniMed Northridge , CA 91325 |
Change to the keypad assembly. |
| P980022/S050 4/13/09 |
MiniLink Real-Time Transmitter and CGMS iPro Digital Recorder | Medtronic MiniMed Northridge , CA 91325 |
Additional inspection step during the manufacture of the device. |
| P980022/S051 4/8/09 |
SOF-SENSOR Glucose Sensor | Medtronic MiniMed Northridge , CA 91325 |
Manufacturing process change to reduce error in accepting or rejecting the sensor. |
| P980035/S132 4/3/09 |
Kappa 600/700, 650 IPG, Kappa 800/900 IPG, EnPulse IPG, Sigma IPG, Medtronic 350 Series IPG, AT500 IPG, EnRhythm IPG, Adapta/Versa/ Sensia IPG | Medtronic, Inc. Mounds View, MN 55112 |
Addition of a new barb welding system. |
| P980035/S133 4/3/09 |
EnRythm, Adapta, Versa, Sensia, Relia | Medtronic, Inc. Mounds View, MN 55112 |
Automate the manufacturing process for the insert-molded bond pad array component. |
| P980049/S046 4/2/09 |
Ovatio VR 6250 and Ovatio DR 6550 ICD | ELA Medical, Inc./ Sorin Group Plymouth , MN 55441 |
Change in the drying method for the hybrid module. |
| P990001/S053 4/3/09 |
Dema Family (includes Clarity DDDR, Clarity SSIR, Diamond III, Ruby III, Topaz III, Jade III, Vita DDDR and Vita II) | Medtronic, Inc. Mounds View, MN 55112 |
Addition of a new barb welding system. |
| P990040/S008 4/28/09 |
Trufill® n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System |
Codman & Shurtleff, Inc. Raynham , MA 02767 |
Change in dose audit frequency for the sterilization procedure. |
| P000039/S030 4/13/09 |
Amplatzer® 45° Delivery and Exchange Systems | AGA Medical Corporation Plymouth , MN 55442 |
Change in manufacturing equipment used to seal the pouches for the device. |
| P000053/S023 4/8/09 |
AMS 800 Artificial Urinary Sphincter | American Medical Systems Minnetonka , MN 55343 |
Use of an alternate flow meter to be used during the testing of the devices’ control pump and the use of an alternate disinfectant cleaner for sanitization of the device tester. |
| P010012/S206 4/16/09 |
EASYTRAK™ Leads | Boston Scientific Corporation St. Paul , MN 55112 |
Acceptance of changes In the welding process parameters. |
| P010015/S066 4/3/09 |
InSync CRT-P, InSync III CRT-P | Medtronic, Inc. Mounds View, MN 55112 |
Addition of a new barb welding system. |
| P010020/S013 4/8/09 |
Acticon Artificial Bowel Sphincter | American Medical Systems Minnetonka , MN 55343 |
Use of an alternate flow meter to be used during the testing of the devices’ control pump and the use of an alternate disinfectant cleaner for sanitization of the device tester. |
| P010031/S148 4/2/09 |
Concerto CRT-D | Medtronic, Inc. Mounds View, MN 55112 |
Modification of the incoming visual inspection sampling plan. |
| P010031/S149 4/3/09 |
Concerto, Concerto II, Consulta CRT-D, Maximo II CRT-D | Medtronic, Inc. Mounds View, MN 55112 |
Automate the manufacturing process for the insert-molded bond pad array component. |
| P010031/S151 4/15/09 |
Concerto CRT-D, Consulta CRT-D, Maximo II CRT-D, Concerto II CRT-D | Medtronic, Inc. Mounds View, MN 55112 |
Changes to the hybrid and final test for the device. |
| P010031/S152 4/22/09 |
InSync ICD, InSync Marquis ICD, InSync II Marquis ICD, InSync III Marquis ICDs, InSync II Protect ICD, InSync III Protect ICD, InSync Sentry ICD, InSync Maximo ICD, Consulta CRT-D, Concerto ICD, Maximo II CRT-D, Concerto II CRT-D |
Medtronic, Inc. Mounds View, MN 55112 |
Change in manufacturing process for capacitor. |
| P010031/S153 4/24/09 |
InSync II/III Marquis, InSync II Protect, InSync Sentry, InSync Maximo, Concerto, Consulta CRT-D, Maximo II CRT-D |
Medtronic, Inc. Mounds View, MN 55112 |
Change in the type of curing oven. |
| P020009/S049 4/8/09 |
Express 2 Coronary Stent System | Boston Scientific Corporation Maple Grove , MN 55311 |
Change from a semi-automated in-process inspection of the Guide Wire Port Bond to an automated in-process inspection. |
| P020024/S025 4/13/09 |
Amplatzer® 180° Delivery and Exchange Systems | AGA Medical Corporation Plymouth , MN 55442 |
Change in manufacturing equipment used to seal the pouches for the device. |
| P020036/S013 4/22/09 |
SMART® Nitinol Stent System and SMART Control Nitinol Stent System | Cordis Corporation Bridgewater , NJ 08807 |
Modifications to the delivery system bonding process. |
| P020036/S014 4/22/09 |
SMART® Nitinol Stent System and SMART Control Nitinol Stent System | Cordis Corporation Warren , NJ 07059 |
Addition of an in-process stent recovery step during the final assembly process. |
| P020045/S027 4/16/09 |
7F Freezor® Cardiac CryoAblation Catheters 7F Freezor® Xtra Surgical CryoAblalion Devices 9F Freezor® MAX Surgical CryoAblation Devices CCT.2 CryoAblation Console (Model 104A2) Sterile Coaxial and Electrical Umbilicals Non-Sterile Auto Connection Box and ECG Cable |
CryoCath Technologies, Inc. Galisteo , NM 87540 |
Outsourcing of components. |
| P030009/S034 4/7/09 |
Driver Coronary Stent Systems | Medtronic Vascular, Inc. Santa Rosa , CA 95403 |
Removal of duplicate visual inspection on the packaging. |
| P030025/S063 4/8/09 |
TAXUS Express 2 Paclitaxel-Eluting Coronary Stent System | Boston Scientific Corporation Maple Grove , MN 55311 |
Change from a semi-automated in-process inspection of the Guide Wire Port Bond to an automated in-process inspection. |
| P030047/S017 4/22/09 |
PRECISE® Nitinol Stent System | Cordis Corporation Bridgewater , NJ 08807 |
Modifications to the delivery system bonding process. |
| P030054/S121 4/28/09 |
Promote / Promote+ CRT-D |
St. Jude Medical Cardiac Rhythm Management Division Sylmar , CA 91342 |
Addition of a flex circuit supplier. |
| P040001/S014 4/16/09 |
X-STOP® Interspinous Process Decompression (IPD) | Medtronic Spine LLC Sunnyvale , CA 94089 |
Change of adhesive used in the manufacturing process of the device. |
| P040016/S035 4/8/09 |
Liberté Coronary Stent System | Boston Scientific Corporation Maple Grove , MN 55311 |
Change from a semi-automated in-process inspection of the Guide Wire Port Bond to an automated in-process inspection. |
| P040024/S036 4/6/09 |
Restylane® and Perlane® Injectable Gels | Medicis Pharmaceutical Corporation Scottsdale , AZ 85256 |
Change in bulk and filling procedures in conjunction with the manufacturing of the device. |
| P040024/S037 4/8/09 |
Restylane® Injectable Gels | Medicis Pharmaceutical Corporation Scottsdale , AZ 85256 |
Changes in the supplier of 1.2 M hydrochloric acid and 0.25 M sodium hydroxide solutions. |
| P040024/S038 4/23/09 |
Restylane® Injectable Gels | Medicis Pharmaceutical Corporation Scottsdale , AZ 85256 |
Change in the volume for delivery of the device. |
| P040027/S014 4/7/09 |
Gore Viatorr® TIPS Endoprosthesis | W.L. Gore & Associates, Inc. Flagstaff , AZ 86001 |
Equipment modification to increase the capacity at an in-process work step. |
| P040037/S018 4/24/09 |
Gore Viabahn® Endoprosthesis | W.L. Gore & Associates, Inc. Flagstaff , AZ 86001 |
Addition of an automated method of removing the mandrel from the endoprosthesis. |
| P040044/S013 4/28/09 |
Mynx® Vascular Closure Device | Access Closure, Inc. Mountain View , CA 94043 |
Use of an adhesive primer to etch the interior of the balloon legs. |
| P050023/S022 4/3/09 |
CardioMessenger TLine, CardioMessenger II, CardioMessenger II-S (TLine) |
Biotronik, Inc. Lake Oswego , OR 97035 |
Change in manufacturing location for external devices to another location in Berlin, Germany. |
| P060008/S014 4/8/09 |
TAXUS Liberté Paclitaxel-Eluting Coronary Stent System | Boston Scientific Corporation Maple Grove , MN 55311 |
Change from a semi-automated in-process inspection of the Guide Wire Port Bond to an automated in-process inspection. |
| P060010/S004 4/14/09 |
The Spanner Temporary Prostatic Stent | Abbeymoor Medical, Inc. Parkers Prairie, MN 56351 |
Change in silicone lubrication and the addition of a coating to a Spanner component. |
| P060022/S004 4/3/09 |
Akreos® Posterior Chamber Intraocular Lens | Bausch & Lomb, Inc. Rochester , NY 14609 |
Alternate measurement system for measuring the Akreos® lens haptics. |
| P060027/S012 4/2/09 |
Ovatio 6750 CRT-D | ELA Medical, Inc./ Sorin Group Plymouth , MN 55441 |
Change in the drying method for the hybrid module. |
| P060033/S034 4/7/09 |
Endeavor Zotarolimus-Eluting Coronary Stent Systems | Medtronic Vascular, Inc. Santa Rosa , CA 95403 |
Removal of duplicate visual inspection on the packaging. |
Summary of PMA Originals & Supplements Approved
Originals: 2
Supplements: 92
Summary of PMA Originals Under Review
Total Under Review: 64
Total Active: 23
Total On Hold: 41
Number Greater Than 180 Days: 7
Summary of PMA Supplements Under Review
Total Under Review: 470
Total Active: 304
Total On Hold: 166
Number Greater Than 180 Days: 25
Summary of All PMA Submissions Received
Originals: 2
Supplements: 100
Summary of PMA Supplement PMA Approval/Denial Decision Times
Number of Approvals: 92
Number of Denials: 0
Average Days Fr Receipt to Decision (Total Time): 103.5
FDA Time: 79.3 Days MFR Time: 24.2 Days
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