Some of the documents on this section of the CDRH Website are available only in PDF format and may not be accessible to those with certain disabilities. If you cannot access the documents you are interested in, please use the accessibility link for assistance. 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. Information about the PDF Reader is available.
PMA Original Approvals
None.PMA Supplemental Approvals
| P830055/S097 6/15/07 135-Day |
LCS Total Knee System | DePuy Orthopaedics, Inc. Warsaw , IN 46581 |
Approval for changing from a manual to an automated tie bar cut off for the LCS Femoral Castings. |
| P840001/S096 6/11/07 Real-Time |
Restore Implantable Neurostimulators | Medtronic Neurological Minneapolis , MN 55432 |
Approval for the Model 39565 Specify™ 5-6-5 Lead Kit. |
| P850035/S031 6/21/07 Real-Time |
SpF®-PLUS 60/W and SpF®-PLUS 60/M | Biomet Manufacturing Corporation Warsaw , IN 465811 |
Approval for device modifications to incorporate identical battery chemistry and implant tester configuration as approved in the SpF-XL IIb device. The device, as modified, will be marketed under the trade name SpF®-PLUS 60/W and SpF®-PLUS 60/M and is indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels. |
| P860019/S216 6/22/07 135-Day |
PTCA Catheters | Boston Scientific Corporation Cardiovascular Maple Grove , MN 55311 |
Approval to implement an alternative manufacturing fixture and to implement a four port Vacuum Decay Tester (VDT). |
| P870072/S034 6/28/07 Real-Time |
Thoratec Ventricular Assist Device (VAD) System | Thoratec Corporation Pleasanton , CA 94588 |
Approval for a material change in the tubing that connects the body of the paracorporeal Thoratec Ventricular Assist Device with the metal Y-connector that splits the line into separate electrical and pneumatic connections. |
| P880086/S148 6/7/07 Real-Time |
Affinity/Integrity/ Victory/Zephyr Families of Pacemakers | St. Jude Medical CRMD Sunnyvale , CA 94086 |
Approval for the use of an alternate configuration for the |
| P890003/S118 6/14/07 Real-Time |
2490 Medtronic CareLink Monitor | Medtronic, Inc. Minneapolis , MN 55432 |
Approval for a change of three components used in the manufacturing o 2490C Medtronic Carelink Monitor. The components being changed are the Voltage Controlled Oscillator (VCXO) and two capacitors. Those are: 1) The VCXO provides an output frequency in response to a given voltage input. For the 2490C Medtronic CareLink Monitor the VCXO supports the telemetry feature of the monitor. The same manufacturer provides both the original part (part number CSX750VCB20.000MUT) and the new part (part number CSX750VJB20.000MUT). 2) There are two capacitors being changed. The capacitor at location C230 is changing from 3300 pF to 6800 pF. The capacitor at location C277 is changing from 470 pF to 6800 pF. Both the current capacitors and the new capacitors are provided by the same manufacturer. |
| P890003/S120 6/7/07 Real-Time |
Medtronic Model 2090 Burbot and Splake Programmers | Medtronic, Inc. Shoreview , MN 55126 |
Approval for an alternate hard disk drive (HDD) used on Medtronic Model 2090 “Burbot” that also includes a minor design change and an alternate floppy disc drive (FDD) used on both Medtronic Model 2090 “Splake” and “Burbot” Carelink programmers. |
| P890003/S122 6/21/07 Real-Time |
Medtronic Vitatron, Thera-i/Prodigy and InSync Pacemakers/Cardiac Resynchronization Therapy Pacing Products | Medtronic, Inc. Cardiac Rhythm Disease Management Shoreview , MN 55126 |
Approval for changes to the XD344 Zener Diode. |
| P900009/S025 6/11/07 135-Day |
Exogen 4000+ Sonic Accelerated Fracture Healing System (SAFHS) | Orthopaedics Smith & Nephew, Inc. Memphis , TN 38116 |
Approval for an additional supplier of the external plastic housing for the main operating unit. This includes the top housing, the bottom housing, the push button and the lens. |
| P900022/S008 6/29/07 180-Day |
All Non-rate Responsive Pacemakers | ELA Medical, Inc. Plymouth , MN 55441 |
Approval for the Orchestra Plus Programmer and Elaview 2.02 programming software. |
| P910018/S011 6/27/07 180-Day |
Liposorber® LA-15 System | Kaneka Pharma America LLC New York , NY 10036 |
Approval to use the Sulflux® KP-05 plasma separator as a component of the Liposorber® LA-15 System. |
| P910031/S024 6/22/07 180-Day |
Merlin PTCA Catheter OTW, NC Merlin PTCA Catheter OTW |
Abbott Vascular, Inc. Temecula , CA 92591 |
Approval for a manufacturing site located at Sterigenics, Germany GmbH, Wiesbaden, Germany. |
| P910066/S023 6/28/07 Real-Time |
SpinaLogic, OL1000, and OL1000 Single Coil Bone Growth Stimulators | DJO, LLC Vista , CA 92081 |
Approval for modifications to the control box for the OL1000, OL1000 Single Coil (Size 2/3/4), and SpinaLogic devices including enlarged LCD icon graphics and prompts, 9 volt alkaline battery power source, and updated device software. The device, as modified, will be marketed under the trade name SpinaLogic, OL1000, and OL1000 Single Coil Bone Growth Stimulators. The OL1000 and OL1000 SC devices are intended for the non-invasive treatment of an established nonunion acquired secondary to trauma, excluding vertebrae and all flat bones. The SpinaLogic device is indicated as an adjunct electrical treatment to primary lumbar spinal fusion surgery for one or two levels. |
| P910077/S074 6/15/07 Real-Time |
Latitude Patient Management System RF Communicator, Model 6482 | Guidant Corporation St. Paul , MN 55112 |
Approval for modifications to the Model 6482 RT Communicator for use on the Latitude Patient Management System. The modifications include a software upgrade (version 1.7.0) and changes to the hardware to increase RF transmit power. |
| P930014/S019 6/15/07 180-Day |
AcrySof® Single-Piece Posterior Chamber IOL | Alcon Research, Ltd. Fort Worth , TX 76134 |
Approval of an alternate manufacturing facility in Cork, Ireland. |
| P950029/S030 6/29/07 180-Day |
All Rate-responsive Pacemakers | ELA Medical, Inc. Plymouth , MN 55441 |
Approval for the Orchestra Plus Programmer and Elaview 2.02 programming software. |
| P960013/S033 6/26/07 Real-Time |
Tendril Lead Models 1788 and 1782 | St. Jude Medical Cardiac Rhythm Management Division Sylmar , CA 91342 |
Approval for ring electrode modifications to Tendril 1788 and 1782 leads, and an outer insulation tube diameter change for Tendril 1782 leads. |
| P960016/S018 6/8/07 Real-Time |
Safire Cardiac Ablation System | St. Jude Medical, Inc. Minnetonka , MN 55345 |
Approval for a labeling modification that allows the Boston Maestro 3000 RT generator to be used with the Safire Bi-directional Ablation Catheter and extension cables. |
| P960040/S138 6/6/07 135-Day |
PRIZM and VITALITY Family of Implantable Cardioverter Defibrillators (ICDs) | Guidant Corporation St. Paul , MN 55112 |
Approval for a reduction in the pre-seal capacitor aging processing time for standard and high energy capacitors. |
| P970003/S076 6/29/07 180-Day |
VNS THERAPY™ System | Cyberonics, Inc. Houston , TX 77058 |
Approval for the VNS Therapy Demipulse™, Model 103 Generator and VNS Therapy Demipulse™ Duo, Model 104 Generator. |
| P970003/S079 6/29/07 Real-Time |
VNS THERAPY™ System | Cyberonics, Inc. Houston , TX 77058 |
Approval for shelf life extension from one to two years. |
| P970003/S082 6/15/07 Special |
VNS Therapy™ System | Cyberonics, Inc. Houston , TX 77058 |
Approval to add two additional in-process quality inspection tests in order to provide additional assurance of reliability of the Model 102 and Model 102R Pulse Generators. |
| D970012/S039 6/6/07 Special |
AMS 700™ Series Product Line of Inflatable Penile Prostheses | American Medical Systems, Inc. Minnetonka , MN 55343 |
Approval for modifications to the Operating Room Manual, Patient Manual, and User’s Guide to clarify the instructions for pump operation. |
| P980016/S100 6/14/07 Real-Time |
2490 Medtronic CareLink Monitor | Medtronic, Inc. Minneapolis , MN 55432 |
Approval for a change of three components used in the manufacturing o 2490C Medtronic Carelink Monitor. The components being changed are the Voltage Controlled Oscillator (VCXO) and two capacitors. Those are: 1) The VCXO provides an output frequency in response to a given voltage input. For the 2490C Medtronic CareLink Monitor the VCXO supports the telemetry feature of the monitor. The same manufacturer provides both the original part (part number CSX750VCB20.000MUT) and the new part (part number CSX750VJB20.000MUT). 2) There are two capacitors being changed. The capacitor at location C230 is changing from 3300 pF to 6800 pF. The capacitor at location C277 is changing from 470 pF to 6800 pF. Both the current capacitors and the new capacitors are provided by the same manufacturer. |
| P980016/S101 6/25/07 Real-Time |
Virtuoso (D154AWG/D154VWC), Marquis VR (7230B/E/Cx), Marquis DR (7274), Maximo DR (7278), Maximo VR (7232/B/Cx), Intrinsic 30 (7287), Intrinsic (7288), and Entrust 30J/35J (D153ATG/D153DRG/ D153VRC/ D154ATG/D154DRG/D154VRC) | Medtronic, Inc. Shoreview , MN 55126 |
Approval for the L325-03 and L325-04 Integrated Circuit (IC) to minimize the potential for a gate-oxide breakdown within the L325-01, L325-02, and L281-04 ICs. |
| P980016/S102 6/6/7 Real-Time |
Medtronic Virtuoso ICD (Models D154 AWG and D154 VWC) | Medtronic, Inc. Shoreview , MN 55126 |
Approval for a change in the barometric pressure requirement from 6 atmospheres absolute (ATA) to 4 ATA and a change in barometric pressure testing methodology used during design verification. |
| P980035/S074 6/21/07 Real-Time |
Kappa 700/600, Kappa 900/800, EnPulse and Adapta/Versa/ Sensia Models | Medtronic, Inc. Cardiac Rhythm Disease Management Shoreview , MN 55126 |
Approval for changes to the XD344 Zener Diode. |
| P980049/S025 6/29/07 180-Day |
All Implantable Cardioverter Defibrillators, Orchestra Plus Programmer and Elaview 2.02 Programming Software | ELA Medical, Inc. Plymouth , MN 55441 |
Approval for the Orchestra Plus Programmer and Elaview 2.02 programming software. |
| P990001/S031 6/21/07 Real-Time |
Medtronic Vitatron, Thera-i/Prodigy and InSync Pacemakers/Cardiac Resynchronization Therapy Pacing Products | Medtronic, Inc. Cardiac Rhythm Disease Management Shoreview , MN 55126 |
Approval for changes to the XD344 Zener Diode. |
| P000025/S021 6/22/07 180-Day |
SONATA TI 100 Cochlear Implant | MED-EL Corporation Durham , NC 27713 |
Approval for the SONATA TI 100Cochlear Implant and is indicated for the following patient populations: Adults eighteen (18) years of age or older who have bilateral, sensorineural hearing impairment and obtain limited benefit from appropriately fitted binaural hearing aids. These individuals typically demonstrate bilateral severe to profound sensorineural hearing loss determined by a pure tone average of 70 dB or greater at 500 Hz, 1000 Hz, and 2000 Hz. Limited benefit from amplification is defined by test scores of 40% correct or less in best-aided listening condition on CD recorded tests of open-set sentence recognition (Hearing In Noise Test [HINT] sentences). Children aged twelve (12) months to seventeen (17) years eleven (11) months must demonstrate a profound, bilateral sensorineural hearing loss with thresholds of 90 dB or greater at 1000 Hz. In younger children, little or no benefit is defined by lack of progress in the development of simple auditory skills in conjunction with appropriate amplification and participation in intensive aural habilitation over a three (3) to six (6) month period. In older children, lack of aid benefit is defined as < 20% correct on the Multi-syllabic Lexical Neighbourhood Test (MLNT) or Lexical Neighbourhood Test (LNT), depending upon the child's cognitive ability and linguistic skills. A three (3) to six (6) month hearing aid trial is required for children without previous experience with hearing aids. Radiological evidence of cochlear ossification may justify a shorter trial with amplification. |
| P000029/S022 6/6/07 135-Day |
Deflux® Injectable Gel | Q-MED Scandinavia, Inc. Princeton , NJ 08540 |
Approval for a change in the test method for the determination of hyaluronic acid content in the finished product. |
| P000029/S023 6/6/07 135-Day |
Deflux® Injectable Gel | Q-MED Scandinavia, Inc. Princeton , NJ 08540 |
Approval to re-qualify the sterilization process for analyzing biological indicators in the finished product. |
| P010003/S010 6/7/07 Real-Time |
BioGlue® Surgical Adhesive | CryoLife, Inc. Kennesaw , GA 30144 |
Approval for the addition of a non-sterile, reusable syringe delivery device. |
| P010015/S029 6/21/07 Real-Time |
Medtronic Vitatron, Thera-i/Prodigy and InSync Pacemakers/Cardiac Resynchronization Therapy Pacing Products | Medtronic, Inc. Cardiac Rhythm Disease Management Shoreview , MN 55126 |
Approval for changes to the XD344 Zener Diode. |
| P010025/S010 6/1/07 Real-Time |
Selenia Full Field Digital Mammography System | Hologic, Inc. Danbury , CT 06810 |
Approval for a change to the blemished pixel specifications. |
| P010031/S068 6/14/07 Real-Time |
2490 Medtronic CareLink Monitor | Medtronic, Inc. Minneapolis , MN 55432 |
Approval for a change of three components used in the manufacturing o 2490C Medtronic Carelink Monitor. The components being changed are the Voltage Controlled Oscillator (VCXO) and two capacitors. Those are: 1) The VCXO provides an output frequency in response to a given voltage input. For the 2490C Medtronic CareLink Monitor the VCXO supports the telemetry feature of the monitor. The same manufacturer provides both the original part (part number CSX750VCB20.000MUT) and the new part (part number CSX750VJB20.000MUT). 2) There are two capacitors being changed. The capacitor at location C230 is changing from 3300 pF to 6800 pF. The capacitor at location C277 is changing from 470 pF to 6800 pF. Both the current capacitors and the new capacitors are provided by the same manufacturer. |
| P010031/S069 6/25/07 Real-Time |
InSync Marquis (7277), InSync II Marquis (7279), InSync II Protect (7295), InSync Sentry (7297/7299), InSync Maximo (7303/7304), and Concerto (C154DWK) | Medtronic, Inc. Shoreview , MN 55126 |
Approval for the L325-03 and L325-04 Integrated Circuit (IC) to minimize the potential for a gate-oxide breakdown within the L325-01, L325-02, and L281-04 ICs. |
| P010031/S070 6/6/07 Real-Time |
Medtronic Concerto CRT-D (Model C154 DWK) | Medtronic, Inc. Shoreview , MN 55126 |
Approval for a change in the barometric pressure requirement from 6 atmospheres absolute (ATA) to 4 ATA and a change in barometric pressure testing methodology used during design verification. |
| P010032/S020 6/11/07 Real-Time |
Genesis, Genesis RC, Genesis XP, and the Eon Neurostimulation Systems |
Advanced Neuromodulation System, Inc. Plano , TX 75024 |
Approval for the use of the Tripole 8, Tripole 8C, Tripole 16C, and Exclaim 8 Lamitrode Series Leads (Models 3208, 3210, 3214, 3224) with the Genesis, Genesis RC, Genesis XP, and Eon Neurostimulation Systems, which are indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with failed back surgery syndrome, intractable low back pain and leg pain. |
| P020004/S023 6/26/07 Special |
Gore Excluder AAA Endoprosthesis | W.L. Gore & Associates, Inc. Flagstaff , AZ 860003 |
Approval for changes to the instructions for use to emphasize the appropriate withdrawal procedures for the delivery catheter and sheath if resistance is felt during removal. These changes included modifications to the directions for use as well as the addition of a warning/ precaution regarding the potential adverse events that may be associated with forcibly withdrawing the delivery catheter through the introducer sheath. |
| P020004/S024 6/5/07 Real-Time |
Gore Excluder AAA Endoprosthesis | W.L. Gore & Associates, Inc. Flagstaff , AZ 860003 |
Approval for modifications to the front olive of the Excluder delivery system. |
| P020009/S034 6/22/07 135-Day |
Express 2 Coronary Stent System | Boston Scientific Corporation Cardiovascular Maple Grove , MN 55311 |
Approval to implement an alternative manufacturing fixture and to implement a four port Vacuum Decay Tester (VDT). |
| P020014/S012 6/15/07 180-Day |
Essure® System for Permanent Birth Control | Conceptus, Inc. Mountain View , CA 94041 |
Approval for design and material changes to the micro-insert, delivery catheter, and introducer of the Essure System. |
| P020026/S029 6/29/07 135-Day |
Cypher® Sirolimus-Eluting Coronary Stent | Cordis Corporation Miami Lakes , FL 33014 |
Approval for the Introduction of Nitrogen Mass Flow Controllers. |
| P030002/S009 6/29/07 Real-Time |
Eyeonics crystalens™ Model AT-45 Accommodating Intraocular Lens (IOL) | Eyeonics, Inc. Aliso Viejo , CA 92656 |
Approval for recommendation to use the Staar MSI-PF injector and MTC-60c cartridge system for injecting the crystalens™ Models AT-45 & AT-45SE) to be added to the Physician Labeling. |
| P030017/S023 6/29/07 180-Day |
Precision™ Spinal Cord Stimulation (SCS) System | Advanced Bionics Sylmar , CA 91342 |
Approval for the Precision OMG (Observational Mechanical Gateway) Connector-M. |
| P040016/S019 6/22/07 135-Day |
Liberté MR & OTW Coronary Stent System | Boston Scientific Corporation Cardiovascular Maple Grove , MN 55311 |
Approval to implement an alternative manufacturing fixture and to implement a four port Vacuum Decay Tester (VDT). |
| P040033/S005 6/27/07 Real-Time |
Birmingham Hip Resurfacing (BHR) System | Smith & Nephew Orthopaedics Memphis , TN 38116 |
Approval for the addition and modification of surgical instruments for use with the BHR System and revisions to the surgical technique. |
| P040034/S009 6/11/07 Real-Time |
DuraSeal® Dural Sealant System | Confluent Surgical, Inc. Waltham , MA 02451 |
Approval for the use of the Kendall Monoject 3 mL polyprophylene syringe in place of the Terumo, Medical 3 mL syringe. |
| P040048/S002 6/8/07 135-Day |
Trilogy AB® Acetabular System | Zimmer, Inc. Warsaw , IN 46581 |
Approval for the addition of the Zimmer Manufacturing B.V. facility located in Ponce, Puerto Rico as an alternative site for manufacturing the VerSys Heritage® femoral stems. |
| P050038/S001 6/6/07 180-Day |
Arista™ AH | Medafor, Inc. Minneapolis , MN 55430 |
Approval for the removal of the urological procedures exclusion from the indications statement. |
| P050047/S001 6/11/07 180-Day |
Juvéderm Hyaluronate Gel Implants | Allergan Santa Barbara , CA 93111 |
Approval for labeling modifications adding additional follow-up data. |
30-Day Notices (135 Day Supplement was not required)
| P810031/S034 6/6/07 |
Healon® Sodium Hyaluronate Viscoelastic Products, Healon, Healon GV, and Healon5 | Advanced Medical Optics Santa Ana , CA 92705 |
Change in the particle filter used in the manufacturing of Healon ophthalmic viscoelastic products. |
| P830061/S039 6/15/07 |
Various Medtronic Lead Components | Medtronic, Inc. Shoreline, MN 55126 |
Change in the molding vendor for the Ring to Pin component. |
| P850089/S055 6/15/07 |
Various Medtronic Lead Components | Medtronic, Inc. Shoreline, MN 55126 |
Change in the molding vendor for the Ring to Pin component. |
| P880081/S033 6/7/07 |
UV-Absorbing Silicone Posterior Chamber Intraocular Lens | Advanced Medical Optics, USA, Inc. | Changes in the extraction method and sampling plan. |
| P880086/S147 6/15/07 |
Affinity, Identity, Verity, Integrity, Victory, and Zephyr Pacemakers | St. Jude Medical CRMD Sunnyvale , CA 94086 |
Modifications to the manufacturing process of dispensing epoxy on a component located on the pacemaker hybrid. |
| P890003/S121 6/15/07 |
Various Medtronic Lead Components | Medtronic, Inc. Shoreline, MN 55126 |
Change in the molding vendor for the Ring to Pin component. |
| P900033/S016 6/13/07 |
Integra® Dermal Regeneration Template | Integra LifeSciences Corporation Plainsboro , NJ 08535 |
Extending the shipping time for the device from 72 hours to 120 hours. |
| P910023/S140 6/1/07 |
Cadence Implantable Cardioverter defibrillator (ICD) | St. Jude Medical CRMD Sunnyvale , CA 94086 |
Alternate supplier of resistor chips for use in the Epic and Atlas devices. |
| P910023/S141 6/6/07 |
Cadence Implantable Cardioverter defibrillator (ICD) | St. Jude Medical CRMD Sunnyvale , CA 94086 |
Enhancements in the manufacture of the high voltage capacitor used in the device. |
| P920014/S027 6/29/07 |
HeartMate XVE Left Ventricular Assist System | Thoratec Corporation Pleasanton , CA 94588 |
Alternate supplier for the polymer used to manufacture the diaphragm used in the device. |
| P930039/S022 6/15/07 |
Various Medtronic Lead Components | Medtronic, Inc. Shoreline, MN 55126 |
Change in the molding vendor for the Ring to Pin component. |
| P950022/S038 6/8/07 |
Tendril and Riata Family of Leads | St. Jude Medical, Inc. Sylmar , CA 91342 |
Alternate supplier of the connector ring component. |
| P950022/S039 6/8/07 |
Tendril and Riata Family of Leads | St. Jude Medical, Inc. Sylmar , CA 91342 |
Alternate supplier of the inner crimp sleeve component. |
| P960006/S022 6/6/07 |
Sweet Tip Rx/Flextend | Guidant Corporation St. Paul , MN 55112 |
Change to the cure time of the Flextend drug collar bond. |
| P960013/S031 6/8/07 |
Tendril and Riata Family of Leads | St. Jude Medical, Inc. Sylmar , CA 91342 |
Alternate supplier of the connector ring component. |
| P960013/S032 6/8/07 |
Tendril and Riata Family of Leads | St. Jude Medical, Inc. Sylmar , CA 91342 |
Alternate supplier of the inner crimp sleeve component. |
| P960028/S021 6/7/07 |
ARRAY Multifocal UV-Absorbing Posterior Chamber Intraocular Lens | Advanced Medical Optics, USA, Inc. | Changes in the extraction method and sampling plan. |
| P960040/S145 6/22/07 |
Vitality HE Devices | Guidant Corporation St. Paul , MN 55112 |
Change to update the V BAT Leakage Current Test software. |
| P970003/S084 6/28/07 |
VNS Therapy™ System | Cyberonics, Inc. Houston , TX 77058 |
Change from a direct metallization process to an electroless copper method for the printed circuit board manufacturing process. |
| D970003/S086 6/8/07 |
Insignia Family of Pulse Generators | Guidant Corporation St. Paul , MN 55112 |
Additional quality control test to verify proper low voltage capacitor orientation in the manufacture of the Insignia family of pulse generators. |
| D970003/S087 6/20/07 |
Insignia Family of Pulse Generators | Guidant Corporation St. Paul , MN 55112 |
Automation of the underfill manufacturing process of Brady Pulse Generator Hybrid components. |
| P970038/S010 6/13/07 |
Access® Hybritech® free PSA | Beckman Coulter, Inc. Chaska , MN 55318 |
Change to modify the purification process for the antibody used in the manufacture of the alkaline phosphatase-antibody conjugate. |
| P970054/S004 6/8/07 |
IgG Enzyme Immunoassay | Hogan & Hartson LLP Washington , DC 20004 |
Change in a quality control test for the in-process device. |
| P970055/S004 6/8/07 |
IgM Enzyme Immunoassay | Hogan & Hartson LLP Washington , DC 20004 |
Change in a quality control test for the in-process device. |
| P980016/S103 6/29/07 |
Marquis DR/VR, Maximo DR/VR, Intrinsic 30/ Intrinsic, EnTrust, Virtuoso, Gem II DR/VDR, Gem DR, Gem III DR/VR, Onyx |
Medtronic, Inc. Shoreview , MN 55126 |
Change in vendor for the 11V and 22V zener diodes used in the hybrid of implantable cardioverter defibrillators and cardiac resynchronization therapy devices. |
| P980050/S028 6/29/07 |
Gem III AT | Medtronic, Inc. Shoreview , MN 55126 |
Change in vendor for the 11V and 22V zener diodes used in the hybrid of implantable cardioverter defibrillators and cardiac resynchronization therapy devices. |
| P990052/S018 6/13/07 |
Vibrant Soundbridge® Middle Ear Implant System | Vibrant MED-EL Hearing technology GmbH Innsbruck , Austria A-6020 |
Change to the sterilization process parameters for the Vibrant Soundbridge® Vibrating Ossicular Prosthesis Implant. |
| P000014/S015 6/6/07 |
VITROS Immunodiagnostic Products Anti-HBs Reagent Pack and Calibrators | Ortho-Clinical Diagnostic, Inc. Rochester , NY 14626 |
Addition of a raw material supplier for uncoated microwells. |
| P000029/S031 6/1/07 |
Deflux® Injectable Gel | Q-MED Scandinavia, Inc. Princeton , NJ 08540 |
Change of an instrument used to test an incoming raw material. |
| P000029/S033 6/18/07 |
Deflux® Injectable Gel | Q-MED Scandinavia, Inc. Princeton , NJ 08540 |
Changes in the calibration method for the pouch sealing equipment. |
| P000043/S017 6/14/07 |
TherMatrix Office Thermotherapy System (TMx-3000) | American Medical Systems, Inc. Minnetonka , MN 55343 |
Implement a replacement component used on the TMx-3000 system’s microwave module printed circuit board. |
| P010012/S150 6/22/07 |
Contak Renewal 3 and Contak Renewal 3 RF Devices | Guidant Corporation St. Paul , MN 55112 |
Change to update the V BAT Leakage Current Test software. |
| P010015/S028 6/15/07 |
Various Medtronic Lead Components | Medtronic, Inc. Shoreline, MN 55126 |
Change in the molding vendor for the Ring to Pin component. |
| P010021/S011 6/21/07 |
VITROS Immunodiagnostic Products Anti-HCV Reagent Pack and VITROS Immunodiagnostic Products Anti-HCV Calibrator | Ortho-Clinical Diagnostics, Inc. Rochester , NY 14626 |
Modification to the formulation of a component, which is then used in t he manufacture of the VITROS Immunodiagnostic Products Anti-HCV Reagent Pack. |
| P010031/S071 6/29/07 |
InSync II Marquis, InSync III Marquis, InSync II Protect, InSync Maximo, InSync Sentry, Concerto | Medtronic, Inc. Shoreview , MN 55126 |
Change in vendor for the 11V and 22V zener diodes used in the hybrid of implantable cardioverter defibrillators and cardiac resynchronization therapy devices. |
| P010055/S004 6/19/07 |
ProstaLund® CoreTherm™ System Microwave Thermotherapy | Hogan & Hartson Washington , DC 20004 |
Change in the material used in the IP-seal of the device. |
| P020004/S022 6/6/07 |
Gore Excluder® AAA Endoprosthesis | W.L. Gore & Associates Flagstaff , AZ 86003 |
Removal of the redundant 100% water entry pressure (WEP) in-process testing for the component tubes of the device. |
| P020026/S035 6/20/07 |
CYPHER® Sirolimus-eluting Coronary Stent on RAPTOR™ Over-the-Wire Delivery System or RAPTORRAIL® Rapid Exchange Delivery System | Cordis Corporation Miami Lakes , FL 33014 |
Implementation of a visual inspection method. |
| P020026/S036 6/20/07 |
CYPHER® Sirolimus-eluting Coronary Stent on RAPTOR™ Over-the-Wire Delivery System or RAPTORRAIL® Rapid Exchange Delivery System (CYPHER® Stent) | Cordis Corporation Miami Lakes , FL 33014 |
Addition of a “tip rounding” step to the Crimp and Pack unit manufacturing operation and update of the visual quality standard requirements for the catheter distal tip. |
| P020045/S022 6/29/07 |
Freezor® Cardiac CryoAblation Catheters, Freezor Xtra and Freezor MAX Cardiac CryoAblation Catheters | CryoCath Technologies, Inc. Santa Fe , NM 87501 |
Change in package sealing. |
| P030024/S006 6/6/07 |
VITROS Immunodiagnostic Products Anti-HBc Reagent Pack and Calibrator | Ortho-Clinical Diagnostics, Inc. Rochester , NY 14626 |
Addition of a raw material supplier for uncoated microwells. |
| P030035/S032 6/15/07 |
Frontier/Frontier II CRT-P Pacemakers | St. Jude Medical CRMD Sunnyvale , CA 94086 |
Modifications to the manufacturing process of dispensing epoxy on a component located on the pacemaker hybrid. |
| P030047/S004 6/29/07 |
PRECISE and PRECISE RX Nitinol Stent Systems | Cordis Corporation Warren , NJ 07059 |
Addition of an inspection step in the production process of the device. |
| P030054/S058 6/6/07 |
Epic HF/Atlas Cardiac Resynchronization Therapy Defibrillator (CRT-D) | St. Jude Medical CRMD Sunnyvale , CA 94086 |
Enhancements in the manufacture of the high voltage capacitor used in the device. |
| P040016/S024 6/8/07 |
Liberté Monorail & Over-the-Wire Coronary Stent System | Boston Scientific Corporation Maple Grove , MN 55331 |
Change from a manual packaging process to a machine-assisted process. |
| P040024/S008 6/7/07 |
Restylane Injectable Gel | Medicis Aesthetics Scottsdale , AZ 85258 |
Changes to the test method for determining conductivity in sodium chloride (NaCl) solution. |
| P040024/S009 6/5/07 |
Restylane Injectable Gel | Medicis Aesthetics Scottsdale , AZ 85258 |
New water system and a new system for managing materials at the Q-Med manufacturing facility. |
| P040027/S005 6/14/07 |
Gore Viatorr Tips Endoprosthesis | W.L. Gore & Associates Flagstaff , AZ 86003 |
Change in vendor for the access sleeve component of the GORE Viatorr Tips Endoprosthesis delivery System. |
| P040043/S014 6/6/07 |
Gore Tag® Thoracic Endoprosthesis | W.L. Gore & Associates Flagstaff , AZ 86003 |
Removal of the redundant 100% water entry pressure (WEP) in-process testing for the component tubes of the device. |
| P040043/S015 6/13/07 |
Gore Tag® Thoracic Endoprosthesis | W.L. Gore & Associates Flagstaff , AZ 86003 |
Change to standardize the current wire testing. |
| P040047/S003 6/21/07 |
Coaptite® | BioForm Medical, Inc. Franksville , WI 53126 |
Nes autoclave for use in the sterilization of Coaptite®. |
| P050037/S002 6/5/07 |
Radiesse | BioForm Medical, Inc. Franksville , WI 53126 |
Installation of additional sterilizers. |
| P050052/S003 6/5/07 |
Radiesse | BioForm Medical, Inc. Franksville , WI 53126 |
Installation of additional sterilizers. |
Summary of PMA Originals & Supplements Approved
Originals: 0
Supplements: 52
Summary of PMA Originals Under Review
Total Under Review: 77
Total Active: 29
Total On Hold: 48
Number Greater Than 180 Days: 4
Summary of PMA Supplements Under Review
Total Under Review: 398
Total Active: 222
Total On Hold: 176
Number Greater Than 180 Days: 20
Summary of All PMA Submissions Received
Originals: 1
Supplements: 79
Summary of PMA Supplement PMA Approval/Denial Decision Times
Number of Approvals: 52
Number of Denials: 0
Average Days Fr Receipt to Decision (Total Time): 109.9
FDA Time: 83.4 Days MFR Time: 26.5 Days
Updated August 7, 2007
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