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.
| P060035 11/6/07 |
ARCHITECT ® CORE-M ™ Reagent Kit ARCHITECT ® CORE-M ™ Calibrators and ARCHITECT ® CORE-M ™ Controls |
Abbott Laboratories Abbott Park , IL 60064 | Approval for the ARCHITECT ® CORE-M ™ Reagent Kit ARCHITECT ® CORE-M ™ Calibrators and ARCHITECT ® CORE-M ™ Controls. The devices is indicted for: The ARCHITECT ® CORE-M ™assay is a chemiluminescent microparticle immunoassay (CMIA) for the qualitative detection of IgM antibody to hepatitis B core antigen (IgM anti-HBc) in human adult and pediatric serum or plasma (dipotassium EDTA, lithium heparin, and sodium heparin) and neonatal serum. A test for IgM anti-HBc is indicated as an aid in the diagnosis of acute or recent hepatitis B virus (HBV) infection in conjunction with other laboratory results and clinical information. The ARCHITECT CORE-M Calibrators are used for the calibration of the ARCHITECT i System when the system is used for the qualitative detection of IgM antibody to hepatitis B core antigen (IgM anti-HBc) using the ARCHITECT CORE-M Reagent Kit. The performance of the ARCHITECT CORE-M Calibrators has not been established with any other IgM anti-HBc assays. The ARCHITECT CORE-M Controls are used for monitoring the performance of the ARCHITECT i System when used for the qualitative detection of IgM antibody to hepatitis B core antigen (IgM anti-HBc) in human adult serum and plasma when using the ARCHITECT CORE-M Reagent Kit. The performance of the ARCHITECT CORE-M Controls has not been established with any other IgM anti-HBc assays. |
| P810002/S060 11/21/07 135-Day |
St. Jude Medical Mechanical Heart Valve | St. Jude Medical, Inc. St. Paul, MN 55117 |
Approval for a change to the supplier of the polyester yarn that is used in the fabrication of: 1) the knitted polyester tubular fabric that is the source material for the St. Jude Medical mechanical heart valve sewing cuffs, and 2) the Hemashield bovine collagen sealed woven polyester vascular graft. |
| P830079/S017 11/28/07 180-Day |
INSTAT Collagen Absorbable Hemostat | Johnson & Johnson Wound Management, Inc. Somerville, NJ 08876 | Approval for the addition of the manufacturing facility located in North Yorkshire, United Kingdom. |
| P860004/S092 11/21/07 Real-Time |
Medtronic Synchromed Pump and Infusion System | Medtronic Neurological Minneapolis, MN 55432 |
Approval for software updates made to N’Vision Programming System model 8840. |
| P870072/S037 11/14/07 Real-Time |
Thoratec TLC-II Portable VAD Driver | Thoratec Corporation Pleasanton, CA 94588 | Approval for reducing the maintenance service interval for the TLC II Portable VAD Driver to 1500 hours from the current 3000 hour interval. |
| P880006/S053 11/6/07 Real-Time |
Sensolog/Dialog/ Regency Family of Pacemakers | St. Jude Medical Sylmar, CA 91342 |
Approval for Model 3330 Version 6.3.1 Software for Model 3650 merlin Patient Care System. |
| P880086/S151 11/6/07 Real-Time |
Affinity/Integrity/ Victory Family of Pacemakers | St. Jude Medical Sylmar, CA 91342 |
Approval for Model 3330 Version 6.3.1 Software for Model 3650 merlin Patient Care System. |
| P890003/S127 11/9/07 180-Day |
Carelink Monitor Family | Medtronic, Inc. Shoreview, MN 55126 | Approval for a manufacturing site located at Plexus-Penang, Penang, Malaysia. |
| P890055/S023 11/26/07 Real-Time |
Codman 3000 Implantable Infusion Pump | Codman & Shurtleff, Inc. Raynham, MA 02767 |
Approval for the following changes to the FlexTip Plus Intraspinal Catheter Kit and to the Codman 3000 pump accessories: 1) replace 3 mm-beveled Tuohy needle with a 4 mm-beveled Tuohy needle; 2) remove a ruler; 3) replace remaining ruler with a new ruler; 4) reduce aeration time for Codman 3000 pump accessories; 5) new packaging design; 6) new packaging materials; 7) update labeling to reflect component changes; and 8) clarify additional non-pyrogenic components and procedural steps. |
| P900022/S009 11/13/07 Real-Time |
All Non-Rate Responsive Implantable Pacemakers | ELA Medical, Inc. Plymouth, MN 55441 | Approval for the Smartview 2.02 UG2 Software as well as associated labeling and operator manual updates. The software modifications are intended to make minor software corrections (Manager, Ovation) and to include a downloadable RAM patch (Symphony/ Rhapsody). |
| P900052/S015 11/6/07 135-Day |
PORT-A-CATH II Low Profile Epidural Implantable Access System | Smiths Medical MD, Inc. St. Paul, MN 55112 |
Approval to use the Herrmann ultrasonic welder. |
| P900060/S039 11/30/07 180-Day |
CarboMedics Prosthetic Heart Valve | CarboMedics, Inc. Austin, TX 78752 |
Approval for a manufacturing site located at Sorin Biomedica Cardio S.R.L., Saluggia ( Vercelli), Italy. |
| P910023/S157 11/6/07 Real-Time |
Cadence Family of Implantable Cardiac Defibrillators | St. Jude Medical Sylmar, CA 91342 |
Approval for Model 3330 Version 6.3.1 Software for Model 3650 merlin Patient Care System. |
| P910077/S077 11/6/07 Real-Time |
Latitude™ Communicator Software & System Software | Boston Scientific Corporation St. Paul, MN 55112 |
Approval for the Latitude Communicator Software (Model 6482), version 2.0 and related System Software (model 6488) that contains Regulated Application Server (RAS) software version 2.3.0 as well as associated labeling and operator manual updates. The software modifications are intended to support new device models, make minor software corrections, and improve ease of use with the Latitude system. |
| P930016/S027 11/9/07 180-Day |
STAR S4 IR Excimer Laser System with Variable Spot Scanning (VSS™) | VISX, Inc. Santa Clara, CA 95051 |
Approval for the upgrade STAR Software version 5.21, STAR Software Version 5.22 and the WaveScan WaveFront System Software Version 3.671. The devices, as modified, will be marketed under the trade names STAR S4 IR Excimer Laser System with Variable Spot Scanning (VSS™) and WaveScan WaveFront® System and are indicated for wavefront-guided (WFG) laser assisted in situ keratimileusis (LASIK) to achieve eye of presbyopic myopes: 1) 40 years or older who may benefit from increased spectacle independence across a range of distances with useful near vision; 2) with myopic astigmatism up to -6.00 D MRSE, with cylinder up to -3.00 D, and minimum pre-operative myopia in their non-dominant eye at least as great as their targeted myopia; 3) with documented evidence of a change in manifest refraction of no more than 0.50 D (in both cylinder and sphere components) for at least one year prior to the date of preoperative examination; and 4) with a successful preoperative trial of monovision or history of monovision experience. |
| P930021/S010 11/28/07 Real-Time |
Emdogain | Straumann Company Andover, MA 01810 |
Approval for two modifications to the device instructions for use: 1) a modification of the description of Emodogain, and 2) a restriction of the recommendation to the use of PrefGel tooth conditioner. |
| P950005/S022 11/28/07 Real-Time |
Celsius RMT Diagnostic/Ablation Catheter | Biosense Webster, Inc. Diamond Bar, CA 91765 |
Approval for minor design changes to the catheter. |
| P950029/S031 11/13/07 Real-Time |
All Rate Responsive Implantable Pacemakers | ELA Medical, Inc. Plymouth, MN 55441 | Approval for the Smartview 2.02 UG2 Software as well as associated labeling and operator manual updates. The software modifications are intended to make minor software corrections (Manager, Ovation) and to include a downloadable RAM patch (Symphony/ Rhapsody). |
| P950037/S054 11/9/07 180-Day |
CardioMessenger LLT, CardioMessenger TLine and CardioMessenger II Home Monitoring Devices for use with Biotronik Pacemakers and Implantable Cardioverter Defibrillators | Biotronik, Inc. Lake Oswego, OR 97035 |
Approval for software, hardware, packaging and labeling modifications to the devices. |
| P960040/S150 11/6/07 Real-Time |
Prizm and Vitality ICD Families | Boston Scientific Corporation St. Paul, MN 55112 |
Approval for the Latitude Communicator Software (Model 6482), version 2.0 and related System Software (model 6488) that contains Regulated Application Server (RAS) software version 2.3.0 as well as associated labeling and operator manual updates. The software modifications are intended to support new device models, make minor software corrections, and improve ease of use with the Latitude system. |
| P970004/S041 11/7/07 Real-Time |
Medtronic InterStim Therapy for Urinary Control | Medtronic, Inc. Minneapolis, MN 55432 |
Approval or software changes to the Model 8840 N’Vision Programming System. |
| P970013/S020 11/6/07 Real-Time |
Microny Family of Pacemakers | St. Jude Medical Sylmar, CA 91342 |
Approval for Model 3330 Version 6.3.1 Software for Model 3650 merlin Patient Care System. |
| P970021/S015 11/5/07 Real-Time |
Gynecare Thermachoice III Uterine Balloon Therapy System | Ethicon, Inc. Somerville, NJ 08876 | Approval for a change in the ethylene oxide sterilization cycle. |
| P970029/S011 11/5/07 180-Day |
TMR2000 Holmium Laser System | Cardiogenesis Corporation Irvine, CA 92618 |
Approval for Pearl 5.0 Handpiece. |
| P970031/S019 11/29/07 135-Day |
FREESTYLE® Aortic Root Bioprosthesis | Medtronic Heart Valves Santa Ana, CA 92705 |
Approval for the addition of a Borate Buffered Saline (BBS) solution pre-rinse to the P5 Amino-Oleic Acid (AOA) process. |
| P970051/S045 11/28/07 Real-Time |
Nucleus 24 Cochlear Implant System | Cochlear Americas Englewood, CO 80112 | Approval for the modifications to Custom Sound 2.0 programming software to provide several enhancements to improve the overall useability for the audiologists, and the capability of linking a Freedom Speech Processor to an implant via an identifier to minimize the possibility of a recipient using the wrong processor. |
| P980016/S110 11/9/07 180-Day |
Marquis, Maximo and EnTrust Devices | Medtronic, Inc. Shoreview, MN 55126 | Approval for a manufacturing site located at Plexus-Penang, Penang, Malaysia. |
| P980041/S010 11/27/07 Real-Time |
Access® AFP Reagents on the Access Immunoassay Analyzer | Beckman Coulter, Inc. Chaska, MN 55318 |
Approval for changing the surfactant used in the wash buffer. |
| P980049/S028 11/13/07 Real-Time |
All Implantable Cardioverter Defibrillators | ELA Medical, Inc. Plymouth, MN 55441 | Approval for the Smartview 2.02 UG2 Software as well as associated labeling and operator manual updates. The software modifications are intended to make minor software corrections (Manager, Ovation) and to include a downloadable RAM patch (Symphony/ Rhapsody). |
| P990064/S019 11/29/07 135-Day |
MOSAIC® Porcine Bioprosthesis | Medtronic Heart Valves Santa Ana, CA 92705 |
Approval for the addition of a Borate Buffered Saline (BBS) solution pre-rinse to the P5 Amino-Oleic Acid (AOA) process. |
| P000009/S023 11/9/07 180-Day |
CardioMessenger LLT, CardioMessenger TLine and CardioMessenger II Home Monitoring Devices for use with Biotronik Pacemakers and Implantable Cardioverter Defibrillators | Biotronik, Inc. Lake Oswego, OR 97035 |
Approval for software, hardware, packaging and labeling modifications to the devices. |
| P000040/S012 11/2/07 Real-Time |
Hydro ThermAblator (HTA) System | Boston Scientific Corporation Marlborough, MA 01752 | Approval for a change to the interface between the thermistor conditioning board, mother board, and temperature controller board to improve connections and mitigate signal loss. |
| P010012/S152 11/9/07 Real-Time |
Easytrak 2 4517, 4518, 4520 & Easytrak 2 IS-1, 4542, 4543, 4544 | Guidant Corporation St. Paul . MN 55112 |
Approval to change the medical adhesive used for the Easytrak 2 family of leads. |
| P010012/S157 11/6/07 Real-Time |
Renewal 3 RF Families | Boston Scientific Corporation St. Paul, MN 55112 |
Approval for the Latitude Communicator Software (Model 6482), version 2.0 and related System Software (model 6488) that contains Regulated Application Server (RAS) software version 2.3.0 as well as associated labeling and operator manual updates. The software modifications are intended to support new device models, make minor software corrections, and improve ease of use with the Latitude system. |
| P010031/S080 11/9/07 180-Day |
InSync Marquis, InSync Sentry, and InSync Maximo Families | Medtronic, Inc. Shoreview, MN 55126 |
Approval for a manufacturing site located at Plexus-Penang, Penang, Malaysia. |
| P010032/S022 11/05/07 Real-Time |
Eon Neurostimulation (IPG) System | Advanced Neuromodulation Systems, Inc. Plano, TX 75024 |
Approval for the PEEK-Optima Antenna Cover. |
| P010033/S012 11/28/07 180-Day |
QuantiFERON-TB Gold | Cellestis, Inc. Valencia, CA 91355 | Approval for a manufacturing site located at Celestis Limited, Victoria, Australia for the bulk formulation of peptides. |
| P020004/S026 11/9/07 135-Day |
Gore EXCLUDER® AAA Endoprosthesis | W.L. Gore & Associates, Inc. Flagstaff, AZ 86001 | Approval for the crush/loading operation and destructive testing (QC) operation to be performed at the Flagstaff Arizona facility. |
| P020004/S031 11/15/07 Real-Time |
Excluder AAA Endoprosthesis | W.L. Gore & Associates, Inc. Flagstaff, AZ 86001 | Approval for design modifications to the packaging tray. |
| P020026/S038 11/21/07 135-Day |
Cypher™ Sirolimus-Eluting Coronary Stent System | Cordis Corporation Miami Lakes, FL 33014 | Approval for a change in classification of delamination defect and sealing parameters. |
| P030006/S013 11/20/07 180-Day |
Prolieve Thermodilatation System | Boston Scientific Corporation Marlborough, MA 01752 | Approval of the post-approval study. |
| P030031/S006 11/28/07 180-Day |
NaviStar Celsius Thermocool Diagnostic/Ablation Catheter | Biosense Webster, Inc. Diamond Bar, CA 91765 |
Approval for modifications to the post-approval study protocol. |
| P030035/S034 11/6/07 Real-Time |
Frontier/Frontier II Family of CRT-Ps | St. Jude Medical Sylmar, CA 91342 |
Approval for Model 3330 Version 6.3.1 Software for Model 3650 merlin Patient Care System. |
| P030054/S070 11/6/07 Real-Time |
Epic HF/Atlas+ HF Family of CRT-Ds | St. Jude Medical Sylmar, CA 91342 |
Approval for Model 3330 Version 6.3.1 Software for Model 3650 merlin Patient Care System. |
| P040001/S005 11/20/07 180-Day |
X-Stop Interspinous Decompression System | Kyphon, Inc. Sunnyvale, CA 94089 | Approval of the post-approval study. |
| P040021/S004 11/15/07 Panel |
SJM Epic™ Valve and SJM Epic™ Supra Valve | St. Jude Medical, Inc. St. Paul, MN 55117 |
Approval for the Epic™ Valve in aortic sizes 21, 23, 25, 27 and 29 mm, and in mitral sizes 27, 29, 31 and 33 mm, and the SJM Epic™ Supra Valve in aortic valve sizes 19, 21, 23, 25 and 27 mm. The device is indicated for patients requiring replacement of a diseased, damaged, or malfunctioning native aortic and/or mitral heart valve. It may also be used as a replacement for a previously implanted aortic and/or mitral prosthetic heart valve. |
| P050012/S011 11/13/07 180-Day |
DexCom™ Seven™ Continuous Glucose Monitoring System, Models PN9500, PN8204 and PN9300 | DexCom, Inc. San Diego, CA 92121 |
Approval for calibration of the DexCom™ Seven™ Continuous Glucose Monitoring System using any FDA cleared blood glucose meter. |
| P050016/S002 11/2/07 Real-Time |
Cormet Hip Resurfacing System | Corin USA Tampa, FL 33612 |
Approval for the addition of intermediate sizes for both the femoral head (42mm, 46mm, 50mm, and 54mm) and the corresponding acetabular cup components within the product line for the Cormet Hip Resurfacing System and revisions to the Cormet Hip Resurfacing labeling to reflect these additional intermediate-sized components. The device is indicated for use in resurfacing hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients having the following conditions: 1) non-inflammatory degenerative arthritis such as osteoarthritis and avascular necrosis; 2) inflammatory arthritis such as rheumatoid arthritis. |
| P050023/S007 11/9/07 180-Day |
CardioMessenger LLT, CardioMessenger TLine and CardioMessenger II Home Monitoring Devices for use with Biotronik Pacemakers and Implantable Cardioverter Defibrillators | Biotronik, Inc. Lake Oswego, OR 97035 |
Approval for software, hardware, packaging and labeling modifications to the devices. |
| P050033/S003 11/19/07 135-Day |
Cosmetic Tissue Augmentation (CTA) Product aka Elevess: 0.5 mL and 1mL | Anika Therapeutics, Inc. Woburn, MA 01801 |
Approval for modifications to manufacturing equipment and procedures. |
| P050047/S002 11/30/07 Special |
Juvéderm Hyaluronate Gel Implants | Allergan Santa Barbara, CA 93111 |
Approval for clarifications to the needle attachment instructions and Juvéderm 30 Physician Instructions. |
30-Day Notices (135 Day Supplement was not required)
| P790007/S021 11/21/07 |
HANCOCK® Modified Orifice (MO) Valved Conduit, Model 150 | Medtronic Heart Valves Santa Ana, CA 92705 |
Alternate manufacturing location for several sub-assembly components. |
| P810006/S030 11/23/07 |
Collastat® Absorbable Collagen Hemostat | Integra Life Sciences Corporation Plainsboro, NJ 07536 | Modification and re-qualification of an existing clean room used to manufacture collagen hemostatic agents. |
| P840001/S101 11/8/07 |
Itrel 3, Restore, Restore Advanced Implantable Neurostimulator | Medtronic Neuromodulation Minneapolis, MN 55432 | Change in the workstation used for welding battery header subassemblies. |
| P840062/S016 11/23/07 |
CollaCote™ Absorbable Hemostat | Integra Life Sciences Corporation Plainsboro, NJ 07536 | Modification and re-qualification of an existing clean room used to manufacture collagen hemostatic agents. |
| P850010/S027 11/23/07 |
Helistat® Absorbable Collagen Hemostat | Integra Life Sciences Corporation Plainsboro, NJ 07536 | Modification and re-qualification of an existing clean room used to manufacture collagen hemostatic agents. |
| P880003/S093 11/30/07 |
PTCA Dilatation Catheters | Cordis Corporation Warren, NJ 07059 |
Change to the biological indicators used to monitor the ethylene oxide sterilization cycles (use of a Self Contained Biological Indicator in place of a Spore Strip Biological Indicator). |
| P880081/S035 11/19/07 |
UV-Absorbing Silicone Posterior Chamber Intraocular Lenses | Advanced Medical Optics, Inc. Santa Ana, CA 92705 |
Use of an additional sterilization chamber for ethylene oxide (EO) sterilization of IOL’s resulting in better temperature distribution, better space utilization, and lower sterilization costs than the current chamber. |
| P890003/S128 11/9/07 |
Prodigy/Thera-I Product Families | Medtronic, Inc. Shoreview, MN 55126 | Change in the workstations used for welding battery header subassemblies. |
| P890003/S130 11/16/07 |
Prodigy/Thera-I IPG | Medtronic, Inc. Shoreview, MN 55126 | Addition of a paperless chart recorder to the sterilization operations at the Tolochenaz, Switzerland manufacturing facility. |
| P900033/S018 11/23/07 |
INTEGRA® Dermal Regeneration Template | Integra Life Sciences Corporation Plainsboro, NJ 07536 | Modification and re-qualification of an existing clean room used to manufacture collagen hemostatic agents. |
| P910077/S080 11/14/07 |
LATITUDE® Inductive Patient Management Communicator | Guidant Corporation Cardiac Rhythm Management St. Paul, MN 55112 |
Replacement of the depanelization equipment and enhancement of a visual inspection for the daughter board of the device. |
| P930014/S022 11/30/07 |
AcrySof® Intraocular Lenses | Alcon Research, Ltd. Fort Worth, TX 76134 |
Alternate formulation mixing master batching process improvement. |
| P930038/S051 11/29/07 |
Angio-Seal™ Vascular Closure Device | St. Jude Medical, Inc. Maple Grove, MN 55311 |
Use of an alternative six (6) hour vacuum drying process. |
| P960009/S044 11/8/07 |
Soletra Neurostimulator | Medtronic Neuromodulation Minneapolis, MN 55432 |
Change in the workstation used for welding battery header subassemblies. |
| P960028/S025 11/19/07 |
Multifocal Silicone and Multifocal Acrylic Posterior Chamber Intraocular Lenses | Advanced Medical Optics, Inc. Santa Ana, CA 92705 |
Use of an additional sterilization chamber for ethylene oxide (EO) sterilization of IOL’s resulting in better temperature distribution, better space utilization, and lower sterilization costs than the current chamber. |
| P960040/S151 11/14/07 |
PRIZM, PRIZM AT, and VITALITY ICDs |
Guidant Corporation Cardiac Rhythm Management St. Paul, MN 55112 |
Addition of a new supplier for thin film resistor chips. |
| P960040/S152 11/21/07 |
VENTAK AV/VR (VENTAK PRIZM) Devices | Guidant Corporation St. Paul, MN 55112 |
Automation of an adhesive application process. |
| P960043/S061 11/21/07 |
Percutaneous Vascular Closure Surgical (PVS) and Suture Medicated Closure (SMC) Systems | Abbott Vascular, Inc. Redwood, CA 94063 |
Change to the sterilization load size from 6 to 13 pallets and a change to the Biological Indicators (BIs), which now consist of an inoculated peebax tube in an envelope. |
| P960043/S062 11/21/07 |
Percutaneous Vascular Closure Surgical (PVS) and Suture Mediated Closure (SMC) Systems | Abbott Vascular, Inc. Redwood, CA 94063 |
Several improvements to the Cuff Swaging Machine. |
| P970003/S092 11/14/07 |
VNS Therapy System | Cyberonics, Inc. Houston, TX 77058 |
Addition of an automated electrical test station. |
| P970004/S044 11/8/07 |
InterStim Neurostimulator | Medtronic Neuromodulation Minneapolis, MN 55432 | Change in the workstation used for welding battery header subassemblies. |
| P970012/S029 11/9/07 |
Kappa 400 DR IPG and Kappa 400 SR IPG Product Families | Medtronic, Inc. Shoreview, MN 55126 | Change in the workstations used for welding battery header subassemblies. |
| P970012/S031 11/16/07 |
Kappa 400 DR IPG and Kappa 400 SR IPG | Medtronic, Inc. Shoreview, MN 55126 | Addition of a paperless chart recorder to the sterilization operations at the Tolochenaz, Switzerland manufacturing facility. |
| D970012/S046 11/13/07 |
AMS 700 Inflatable Penile Prosthesis | American Medical Systems Minnetonka, MN 55343 |
Changes in cleaning processes to remove residual manufacturing materials. |
| P970020/S051 11/30/07 |
Multi-Link RX Ultra™ Coronary Stent System | Abbott vascular, Inc. Temecula, CA 92591 | Addition of a visual inspection step to the manufacturing process. |
| P970031/S022 11/21/07 |
FREESTYLE® Aortic Root Bioprosthesis, Models 995, 995MS and 995CS | Medtronic Heart Valves Santa Ana, CA 92705 |
Alternate manufacturing location for several sub-assembly components. |
| D980003/S006 11/21/07 |
KERAMOS™ Ceramic/Ceramic Total Hip System | Encore Medical, L.P. Austin, TX 78758 |
Supplier to implement new software to the manufacturing line to allow polished inserts to be reworked following inspection in one of the two inner sphere polishing stations, while the other station continues to be used for initial production. |
| P980016/S112 11/16/07 |
Marquis DR/VR ICD, Maximo DR/VR ICD, Onyx ICD, Intrinsic ICD, EnTrust ICD, Virtuoso ICD, GEM DR ICD, GEM II DR/VR ICD, Gem III DR/VR ICD | Medtronic, Inc. Shoreview, MN 55126 | Addition of a paperless chart recorder to the sterilization operations at the Tolochenaz, Switzerland manufacturing facility. |
| P980016/S113 11/16/07 |
Virtuoso Implantable Cardioverter Defibrillator (ICDs) Devices | Medtronic, Inc. Shoreview, MN 55126 | Change to the cleaning process in the flex assembly process. |
| P980035/S078 11/9/07 |
Adapta/Versa/ Sensia IPG, Kappa 600/700 IPG, Kappa 800/900 IPG EnPulse, Sigma IPG, and Sigma 350 IPG Product Families |
Medtronic, Inc. Shoreview, MN 55126 | Change in the workstations used for welding battery header subassemblies. |
| P980035/S080 11/16/07 |
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. Shoreview, MN 55126 | Addition of a paperless chart recorder to the sterilization operations at the Tolochenaz, Switzerland manufacturing facility. |
| P980040/S019 11/19/07 |
Sensar Soft Acrylic Posterior Chamber Intraocular Lenses | Advanced Medical Optics, Inc. Santa Ana, CA 92705 |
Use of an additional sterilization chamber for ethylene oxide (EO) sterilization of IOL’s resulting in better temperature distribution, better space utilization, and lower sterilization costs than the current chamber. |
| P980043/S014 11/21/07 |
HANCOCK® II Porcine Bioprosthesis, Models T505 and T510 | Medtronic Heart Valves Santa Ana, CA 92705 |
Alternate manufacturing location for several sub-assembly components. |
| P980050/S031 11/16/07 |
GEM III AT ICD | Medtronic, Inc. Shoreview, MN 55126 | Addition of a paperless chart recorder to the sterilization operations at the Tolochenaz, Switzerland manufacturing facility. |
| P990001/S032 11/9/07 |
C-Series Implantable Pulse Generator (IPG), T-Series IPG, Diamond II, Ruby II, Topaz II, Jade II, Diamond 3, Ruby 3, Topaz 3, Jade 3, Clarity IPG, Vita IPG, Vita 2 IPG, and Selection Product Families | Medtronic, Inc. Shoreview, MN 55126 | Change in the workstations used for welding battery header subassemblies. |
| P990001/S034 11/16/07 |
Clarity DDR, Clarity SSIRR, Diamond III, Ruby III, Topaz III, Jade III, Vita III DDDR, Vita II |
Medtronic, Inc. Shoreview, MN 55126 | Addition of a paperless chart recorder to the sterilization operations at the Tolochenaz, Switzerland manufacturing facility. |
| P990009/S020 11/30/07 |
Floseal® Hemostatic Matrix | Baxter Healthcare Corporation McGaw Park, IL 60085 |
Change to a new warehouse for storage of finished devices and raw materials. |
| P990040/S006 11/30/07 |
TRUFIL n-BCA Liquid Embolic System | Cordis Neurovascular Miami Lakes, FL 33014 | Change to the biological indicators used to monitor the ethylene oxide sterilization cycles (use of a Self Contained Biological Indicator in place of a Spore Strip Biological Indicator). |
| P990064/S021 11/21/07 |
MOSAIC® Porcine Bioprosthesis, Models 305 and 310 | Medtronic Heart Valves Santa Ana, CA 92705 |
Alternate manufacturing location for several sub-assembly components. |
| P990080/S028 11/19/07 |
CeeOn and Tecnis UV-Absorbing Posterior Chamber Intraocular Lenses | Advanced Medical Optics, Inc. Santa Ana, CA 92705 |
Use of an additional sterilization chamber for ethylene oxide (EO) sterilization of IOL’s resulting in better temperature distribution, better space utilization, and lower sterilization costs than the current chamber. |
| P000053/S012 11/13/07 |
AMS 800 Artificial Urinary Sphincter | American Medical Systems Minnetonka, MN 55343 |
Changes in cleaning processes to remove residual manufacturing materials. |
| P000053/S013 11/5/07 |
AMS 800 Urinary Control System | American Medical Systems Minnetonka, MN 55343 | Implementation of additional press equipment for mold manufacturing of the AMS 800 Artificial Urinary Sphincter. |
| P010012/S158 11/21/07 |
EASYTRAK 2 Family of Leads | Guidant Corporation St. Paul, MN 55112 |
Addition of a new supplier for an extrusion process. |
| P010012/S159 11/14/07 |
CONTAK RENEWAL CRT-Ds |
Guidant Corporation Cardiac Rhythm Management St. Paul, MN 55112 |
Addition of a new supplier for thin film resistor chips. |
| P010012/S161 11/21/07 |
CONTAK CD / EASYTRAK Devices | Guidant Corporation St. Paul, MN 55112 |
Automation of an adhesive application process. |
| P010015/S033 11/9/07 |
InSync Cardiac Resynchronization Therapy Pacemaker (CRT-P) and InSync III CRT-P Product Familes | Medtronic, Inc. Shoreview, MN 55126 | Change in the workstations used for welding battery header subassemblies. |
| P010015/S035 11/16/07 |
InSync CRT-P, InSync II CRT-P | Medtronic, Inc. Shoreview, MN 55126 | Addition of a paperless chart recorder to the sterilization operations at the Tolochenaz, Switzerland manufacturing facility. |
| P010031/S082 11/16/07 |
InSync CRT-D, InSync II Protect ICD, InSync Sentry ICD, InSync Maximo ICD, InSync Marquis ICD, Concerto ICD | Medtronic, Inc. Shoreview, MN 55126 | Addition of a paperless chart recorder to the sterilization operations at the Tolochenaz, Switzerland manufacturing facility. |
| P010031/S083 11/16/07 |
Concerto Cardiac Resynchronization Therapy Defibrillator (CRT-Ds) Devices |
Medtronic, Inc. Shoreview, MN 55126 | Change to the cleaning process in the flex assembly process. |
| P020004/S030 11/9/07 |
Gore EXCLUDER® AAA Endoprosthesis | W.L. Gore & Associates, Inc. Flagstaff, AZ 86001 | Expansion of the environment for the stent winding process. |
| P020036/S009 11/30/07 |
SMART & SMART Control Nitinol Stent System | Cordis Corporation Warren, NJ 07059 |
Change to the biological indicators used to monitor the ethylene oxide sterilization cycles (use of a Self Contained Biological Indicator in place of a Spore Strip Biological Indicator). |
| P030009/S016 11/28/07 |
Driver and Micro-Driver Coronary Stent Systems | Medtronic Vascular Santa Rosa, CA 95403 | Changes to the inspection process. |
| P030017/S028 11/21/07 |
Precision® Spinal Cord Stimulator System | Advance Bionics Corp. Sylmar, CA 91342 |
Change in the technique for verifying continuity of SCS Leads. |
| P030031/S008 11/14/07 |
NaviStar and Celsius ThermoCool Diagnostic/Ablation Deflectable Tip Catheters | Biosense Webster, Inc. Diamond Bar, CA 91765 |
Increase in the sterilization pallet size from a 6-pallet load to a 10-pallet load. |
| P030039/S007 11/30/07 |
Coseal® Surgical Sealant | Baxter Healthcare Corporation McGaw Park, IL 60085 |
Change to a new warehouse for storage of raw materials and finished devices. |
| P030047/S007 11/8/07 |
Cordis PRECISE® Nitinol Stent System (OTW) | Cordis Corporation Warren, NJ 07059 |
Change to the filler ingredient in the UV adhesive. |
| P030047/S008 11/30/07 |
PRECISE, PRECISE Rx, & PRECISE PRO Rx Nitinol Stent System | Cordis Corporation Warren, NJ 07059 |
Change to the biological indicators used to monitor the ethylene oxide sterilization cycles (use of a Self Contained Biological Indicator in place of a Spore Strip Biological Indicator). |
| P040020/S006 11/30/07 |
AcrySof® Intraocular Lenses | Alcon Research, Ltd. Fort Worth, TX 76134 |
Alternate formulation mixing master batching process improvement. |
| P040023/S010 11/14/07 |
Duraloc® Option Ceramic Hip System | DePuy Orthopaedics, Inc. Warsaw, IN 46581 | Implementation of a manufacturing change made by the contract supplier, CeramTec. |
| P040036/S005 11/14/07 |
NaviStar and Celsius ThermoCool Diagnostic/Ablation Deflectable Tip Catheters | Biosense Webster, Inc. Diamond Bar, CA 91765 |
Increase in the sterilization pallet size from a 6-pallet load to a 10-pallet load. |
| P040044/S003 11/14/07 |
Mynx™ Vascular Closure System | AccessClosure, Inc. Mountain View, CA 94043 | Use of UV/ Cyanoacrylate adhesive for the balloon proximal bond and use of Balloon blowing and Tubing Necker machines. |
| P050009/S005 11/30/07 |
C2-A Taper Acetabular System | Biomet Orthopedics, Inc. Warsaw, IN 46581 |
Change by the supplier to implement new software on the manufacturing line. |
| P050017/S001 11/9/07 |
Zilver® Vascular Stent | Cook, Inc. Bloomington, IN 47402 | Change in sterilant. |
Summary of PMA Originals & Supplements Approved
Originals: 1
Supplements: 50
Summary of PMA Originals Under Review
Total Under Review: 71
Total Active: 26
Total On Hold: 45
Number Greater Than 180 Days: 3
Summary of PMA Supplements Under Review
Total Under Review: 436
Total Active: 272
Total On Hold: 164
Number Greater Than 180 Days: 12
Summary of All PMA Submissions Received
Originals: 1
Supplements: 120
Summary of PMA Supplement PMA Approval/Denial Decision Times
Number of Approvals: 50
Number of Denials: 0
Average Days Fr Receipt to Decision (Total Time): 107.0
FDA Time: 67.2 Days MFR Time: 39.8 Days
Updated July 15, 2008
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