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
P050024 |
CryoCor CryoAblation System |
CryoCor, Inc. |
Approval for the CryoCor CryoAblation System. The device is indicated for use in the ablation of isthmus-dependent right atrial flutter in patients 18 years of age or older. |
P050043 |
Femoral Introducer Sheath and Hemostasis (FISH™) Device 5,6, and 8 French |
Morris Innovative research, Inc. |
Approval for the Femoral Introducer Sheath and Hemostasis (FISH™) device 5, 6, and 8 French. The device is indicated as follows: The Femoral Introducer Sheath and Hemostasis (FISH™) device is intended for hemostatic closure of femoral artery access sites. The system is indicated for use in reducing time to hemostasis and time to ambulation in patients who have undergone diagnostic procedures using 5, 6, or 8 French procedural sheaths. |
PMA Supplemental Approvals
| P790017/S086 8/17/07 135-Day |
Gruntzig Dilaca Coronary Artery Balloon Dilatation Catheter | Medtronic Vascular, Inc. Santa Rosa, CA 95403 |
Approval to: 1) introduce an automated inflation device, replacing the current manual process, to inflate PTCA balloons prior to in-process functional testing; and 2) reduce the number of samples which are taken to monitor particulate levels in nitrogen gas and compressed air. |
| P810031/S031 8/16/07 180-Day |
Healon®, Healon GV® and Healon5® Sodium Hyaluronate Ophthalmic Viscoelastic Devices |
Advanced Medical Optics, Inc. Santa Ana, CA 92705 |
Approval for the transfer and expansion of the quality control microbiology laboratory used for the Healon®, Healon GV® and Healon5® Sodium Hyaluronate Ophthalmic Viscoelastic Devices. The transfer includes test methods, personnel, and equipment from building 16 to building 23 located in Uppsala, Sweden. |
| P810031/S033 8/30/07 135-Day |
Healon®, Healon GV® and Healon5® Sodium Hyaluronate Ophthalmic Viscoelastic Devices |
Advanced Medical Optics, Inc. Santa Ana, CA 92705 |
Approval for a different release agent to be used with their existing PETG material in the outer blister tray for the secondary packaging of all of the Healon Ophthalmic viscoelastic products. The device, as modified, will be marketed under the trade names: Healon®, Healon GV® and Healon5® Sodium Hyaluronate and is intended to be introduced into the eye to aid performance of surgery, such as to maintain anterior chamber depth, preserve tissue integrity, protect tissue from surgical trauma, or function as a tamponade during retinal reattachment. |
| P830055/S099 8/14/07 Real-Time |
LCS Total Knee System – P.F.C. Sigma 4N RPF Femoral Component | DePuy Orthopaedics, Inc. Warsaw, IN 56481 |
Approval for the addition of an intermediate size P.F.C. Sigma 4N RPF Femoral Component. |
| P840064/S032 8/30/07 180-Day |
Viscoat®, Duovisc® and DisCoVisc® Ophthalmic Viscosurgical Devices | Alcon Research, Ltd. Fort Worth, TX 76134 |
Approval for an additional alternate sterilization site at Sterigenics, Wiesbaden, Germany. |
| P880003/S089 8/29/07 180-Day |
DURA STAR™ Rx PTCA Dilatation Catheter | Cordis Corporation Warren, NJ 07059 |
Approval for a new catheter model. The device, as modified, will be marketed under the trade name DURA STAR™ Rx PTCA Balloon Dilatation Catheter and is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion. In addition, the DURA STAR™ Rx PTCA Dilatation Catheter is indicated for post-delivery expansion of balloon expandable stents. |
| P880003/S090 8/31/07 180-Day |
FIRE STAR™ Rx PTCA Dilatation Catheter | Cordis Corporation Miami Lakes, FL 33014 |
Approval for a new catheter model. The device, as modified, will be marketed under the trade name FIRE STAR™ Rx PTCA Balloon Dilatation Catheter and is indicated for balloon dilatation for the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion. |
| P890047/S019 8/30/07 180-Day |
Provisc® Ophthalmic Viscosurgical Devices | Alcon Research, Ltd. Fort Worth, TX 76134 |
Approval for an additional alternate sterilization site at Sterigenics, Wiesbaden, Germany. |
| P900009/S027 8/16/07 Real-Time |
Exogen 4000+ Bone Healing System | Smith & Nephew, Inc. Memphis, TN 38116 |
Approval for changes in internal device circuitry as mitigation against known device failure mechanisms which do not impact upon ultrasound output or signal parameters. |
| P900052/S014 8/28/07 135-Day |
PORT-A-CATH Epidural and PORT-A-CATH II Low Profile Epidural Systems |
Smiths Medical MD, Inc. St. Paul, MN 55112 |
Approval for a change to the in-process manufacturing package inspection procedure of the PORT-A-CATH Epidural and PORT-A-CATH II Low Profile Epidural Systems. The modifications to the in-process pouch seal inspection includes: 1) Five test intervals will be performed over a single day versus three test intervals per each manufacturing job. 2) The current five pouches tested using the pull test will be reduced to two pouches per test period and the current two pouches inspected using hand peel and visual verification will be increased to five pouches per test period. 3) The results of the gage pull test and visual inspection will be recorded in the individual job folder per established test interval. 4) The pouch sealing process parameter settings will continue to be recorded for each job and each inspection interval. |
| P910077/S053 8/6/07 135-Day |
VENTAK PRx/MINI ICD System | Guidant/ Boston Scientific CRM St. Paul, MN 55112 |
Approval for an update to the visual inspection criteria for tantalum and ceramic capacitors. |
| P910077/S075 8/3/07 180-Day |
Various ICD Systems | Guidant Corporation St. Paul, MN 55112 |
Approval for a manufacturing site located at Plexus Electrical Assembly, Buffalo Grove, Illinois. |
| P920023/S022 8/8/07 Special |
UroLume® Endoprosthesis | American Medical Systems Minnetonka, MN 55343 |
Approval for a labeling change to add hypospadias as a precaution when using the UroLume for the treatment of recurrent bulbar urethral strictures. |
| P940031/S046 8/6/07 135-Day |
DISCOVERY/ MERIDIAN | Guidant/ Boston Scientific CRM St. Paul, MN 55112 |
Approval for an update to the visual inspection criteria for tantalum and ceramic capacitors. |
| P940040/S007 8/30/07 180-Day |
Amplicor Mycobacterium Tuberculosis Test | Roche Molecular Systems, Inc. Pleasanton, CA 94566 |
Approval for a manufacturing site located in Somerville, New Jersey for oligonucleotide and enzyme manufacturing. |
| P950037/S051 8/31/07 Real-Time |
Philos and Axios Family of Pulse Generators | Biotronik, Inc. Lake Oswego, OR 97035 |
Approval for changes to the integrated circuit packaging, circuit board substrate, header assembly, and the TEL 3000 interface in the Philos and Axios family of pulse generators. |
| P960013/S029 8/6/07 135-Day |
Tendril Family of Lead | St. Jude Medical, CRMD Sylmar, CA 91342 |
Approval for an alternate circumferential weld to the current multiple spot welds to connect the inner coil to the helix shaft. |
| P960013/S030 8/21/07 135-Day |
Tendril Family of Lead | St. Jude Medical, CRMD Sylmar, CA 91342 |
Approval for an alternative weld pattern. |
| P960040/S088 8/6/07 135-Day |
PRIZM/VITALITY | Guidant/ Boston Scientific CRM St. Paul, MN 55112 |
Approval for an update to the visual inspection criteria for tantalum and ceramic capacitors. |
| D970003/S051 8/6/07 135-Day |
PULSAR/ DISCOVERY/ MERIDIAN/ INSIGNIA/ INTELLIS/NEXUS | Guidant/ Boston Scientific CRM St. Paul, MN 55112 |
Approval for an update to the visual inspection criteria for tantalum and ceramic capacitors. |
| P970003/S086 8/30/07 Real-Time |
VNS Therapy™ System | Cyberonics, Inc. Houston, TX 77058 |
Approval for a material change to the Model 220 Patient Essentials Kit Patient Magnet. |
| P980016/S099 8/7/07 Real-Time |
EnTrust 35J (D154ATG, D15DRG, D154VRC) and Virtuoso (D154AWG, D154VWC) ICDs | Medtronic CRMD Shoreview, MN 55126 |
Approval for a change to the capacitor perimeter insulation tape. |
| P980031/S007 8/21/07 180-Day |
INTACS® Prescription Inserts | Addition Technology, Inc. Sunnyvale, CA 94089 |
Approval for packaging operations for the INTACS Prescription Inserts to be transferred to the Sunnyvale, California facility. |
| P980043/S012 8/29/07 Real-Time |
Hancock® II Bioprosthesis, Models T505, T510 | Medtronic Heart Valves Santa Ana, CA 92705 |
Approval to reduce the bioprosthesis rinsing time prior to implantation. The approval applies to all sizes of the aortic and mitral Hancock® II Bioprosthesis. |
| P990033/S014 8/9/07 180-Day |
PepGen P-15, PepGen P-15 flow and PepGen P-15 Putty Bone Grafting Material with Biological Component | Dentsply International York, PA 17405 |
Approval to relocate the manufacturing site to Dentsply Specialty materials located in York Pennsylvania. |
| P990046/S013 8/16/07 180-Day |
ATS Open Pivot™ Bileaflet Heart Valves | ATS Medical, Inc. Minneapolis, MN 55447 |
Approval for 22/25 mm mitral valves, Models 501DM22, 503DM22 and 500DM25. |
| P990064/S018 8/29/07 Real-Time |
MOSAIC® Porcine Bioprosthesis, Models 305, 310 | Medtronic Heart Valves Santa Ana, CA 92705 |
Approval to reduce the bioprosthesis rinsing time prior to implantations. The request applies to all sizes of the aortic and mitral MOSAIC® Bioprosthesis. |
| P990066/S029 8/1/07 Real-Time |
Senographe Essential Full Field Digital Mammography System | GE Healthcare Waukesha, WI 53188 |
Approval for modifications of the GE Senographe Essential Full Field Digital Mammography System to permit use in mobile vans. |
| P990074/S017 8/22/07 180-Day |
Inamed Saline Breast Implants | Allergan Medical Goleta, CA 93117 |
Approval for a manufacturing site in La Aurora de Heredia, Costa Rica. |
| P000008/S010 8/22/07 180-Day |
Lap-Band Adjustable Gastric Banding | Allergan Medical Goleta, CA 93117 |
Approval for a manufacturing site in La Aurora de Heredia, Costa Rica. |
| P000010/S009 8/30/07 180-Day |
Amplicor HCV Test, version 2.0 | Roche Molecular Systems, Inc., Pleasanton, CA 94566 |
Approval for a manufacturing site located in Somerville, New Jersey for oligonucleotide and enzyme manufacturing. |
| P000012/S013 8/30/07 180-Day |
Cobas Amplicor HCV Test, version 2.0 | Roche Molecular Systems, Inc., Pleasanton, CA 94566 |
Approval for a manufacturing site located in Somerville, New Jersey for oligonucleotide and enzyme manufacturing. |
| P000039/S029 8/16/07 180-Day |
AMPLATZER Septal Occluder | AGA Medical Corporation Golden Valley, MN 55427 |
Approval for modifications to the post approval study. |
| P000039/S021 8/2/07 180-Day |
AMPLATZER Septal Occluder | AGA Medical Corporation Golden Valley, MN 55427 |
Approval for the addition of the 30 mm device size to the “Cribriform” product line. |
| P000040/S010 8/8/07 180-Day |
Hydro ThermAblator System (HTA System) | Boston Scientific Corporation Marlborough, MA 01752 |
Approval for a manufacturing site located at Nexcore Technology, Inc., Waldwick, New Jersey to manufacture the following components: HTA system console, reusable heater canister, and scope adapter. |
| P000041/S006 8/30/07 180-Day |
OnGuard™ | Riverain Medical Miamisburg, OH 45342 |
Approval for a new trade name. The device, as modified, will be marketed under the trade name OnGuard™ and is indicated to identify and mark regions of interest (ROIs) on frontal chest radiographic films from adult males with an increased risk for lung cancer to bring ROIs to the attention of the radiologist after the initial reading has been completed. Thus the system assists the radiologist in minimizing observational oversights by identifying areas on the original chest films that may warrant a second review. |
| P010012/S078 8/6/07 135-Day |
CONTAK RENEWAL CD | Guidant/ Boston Scientific CRM St. Paul, MN 55112 |
Approval for an update to the visual inspection criteria for tantalum and ceramic capacitors. |
| P010012/S151 8/24/07 Real-Time |
CONTAK RENEWAL 3 RF | Guidant Corporation St. Paul, MN 55112 |
Approval for the following changes to the CONTAK RENEWAL 3 RF models H210, H215, H217, and H219: 1) Digital IC pad change to address premature battery depletion. 2) Hybrid Motherboard DFN trace re-routing from outside layer “4” to an inside layer “3” to reduce electrical field intensity and possible arcing. 3) Trim Target Adjustment. |
| P010014/S005 8/3/07 180-Day |
Oxford Meniscal Unicompartmental Knee System | Biomet, Inc. Warsaw, IN 46581 |
Approval for a sterilization site located at Isotron Plc, Berkshire, United Kingdom. |
| P010014/S006 8/30/07 135-Day |
Oxford Meniscal Unicompartmental Knee System | Biomet, Inc. Warsaw, IN 46581 |
Approval for the following changes in the manufacturing processes for the tibial, meniscal bearing, and femoral components for the Oxford Meniscal Unicompartmental Kneed System: 1) addition of inspection checks; and 2) addition of prewashes. |
| P010029/S004 8/23/07 Real-Time |
Euflexxa (1% Sodium Hyaluronate) | Ferring Pharmaceuticals, Inc. Parsippany, NJ 07054 |
Approval for a change in inflammation testing for bulk sodium hyaluronate from oxidative burst testing to an IL-6 ELISA method. |
| P010030/S009 8/17/07 Real-Time |
LifeVest WCD 3000 | Zoll Lifecor Corporation Pittsburgh, PA 15238 |
Approval for a design change to the LifeVest model WCD 3000 Battery pack to improve its immunity to an electrostatic discharge (ESD) event. |
| P010031/S067 8/7/07 Real-Time |
Concerto (C154DWK) CRT-D |
Medtronic CRMD Shoreview, MN 55126 |
Approval for a change to the capacitor perimeter insulation tape. |
| P020002/S003 8/30/07 180-Days |
ThinPrep® Imaging System | Cytyc Surgical Products Marlborough, MA 01752 |
Approval for a manufacturing site located at Cytyc, Marlborough, Massachusetts. |
| P020014/S014 8/7/07 180-Day |
Conceptus Essure® System for Permanent Birth Control | Conceptus, Inc. Mountain View, CA 94041 |
Approval for a manufacturing site change from Conceptus, Inc. in Mountain View, California to a contract manufacturer in Chihuahua, Mexico. |
| P020018/S016 8/30/07 135-Day |
Zenith® AAA Endovascular Graft and H&L-B One-Shot™ Introduction System | Cook, Inc. Bloomington, IN 47402 |
Approval for the addition of alternate vendors for 1) the 5-0 green braided polyester suture and 2) the 5-0 blue monofilament polypropylene suture. |
| P020022/S005 8/1/07 135-Day |
Versant® HCV RNA 3.0 Assay (bDNA) | Bayer Healthcare, LLC Walpole, MA 02032 |
Approval for transfer of the manufacture of the Wash reagents ( Wash A and Wash B) to a contract manufacturer. The number of bottles per lot will be increased for both Wash A and Wash B. |
| P020056/S001 8/22/07 180-Day |
Responsive Inamed Silicone Filled Breast Implants | Allergan Medical Goleta, CA 93117 |
Approval for a manufacturing site in La Aurora de Heredia, Costa Rica. |
| P030005/S022 8/6/07 135-Day |
RENEWAL TR | Guidant/ Boston Scientific CRM St. Paul, MN 55112 |
Approval for an update to the visual inspection criteria for tantalum and ceramic capacitors. |
| P030022/S003 8/14/07 135-Day |
Reflection Ceramic Acetabular System | Smith & Nephew, Inc. Memphis, TN 38116 |
Approval for a change to the porous coating process for the Reflection ceramic acetabular shell test coupon. |
| P030029/S001 8/2/07 135-Day |
ADVIA Centaur Anti-HBs ReadyPack Reagents & Calibrators | Siemens Medical Solutions Diagnostics East Walpole, MA 02032 |
Approval for an additional component supplier. |
| P040003/S004 8/2/07 180-Day |
ExAblate® 2000, Version 4.22 | InSightec, Inc. Dallas, TX 75207 |
Approval for several hardware enhancements and software error corrections. |
| P040013/S009 8/10/07 Special |
GEM 21S (Growth Enhanced Matrix) | Biomimetic Therapeutics Inc. Franklin, TN 37067 |
Approval for the new reference standard, which is used in the following analytical methods: RP-HPLC, SEC, SDS-PAGE, UV, bioassay, ELISA, and phH. |
| P040042/S009 8/21/07 180-Day |
Safire™ TX Cardiac Ablation Catheter and Interface Cables | Irvine Biomedical, Inc. Irvine, CA 92614 |
Approval for the Safire™ TX Cardiac Ablation Catheter Model 1642 and the Models 1740-SW and 1779-SE Interface Cables. |
| P040045/S001 8/14/07 180-Day |
VISTAKON® (senofilcon A) Contact Lens | VISTAKON® Division of Johnson & Johnson Vision Care, Inc. Jacksonville, FL 32256 |
Approval for an additional indication for therapeutic use for the VISTAKON® (senofilcon A) Contact Lens. The device, as modified, will be marketed under the trade name ACUVUE® OASYS™ Brand Contact Lenses with HYDRACLEAR™ PLUS (senofilcon A) and is additionally indicated for therapeutic use as a bandage lens for the following acute and chronic conditions: 1) For corneal protection in lid and corneal abnormalities such as entropion, trichiasis, tarsal scars and recurrent corneal erosion. In addition it is indicated for protection where sutures or ocular structure malformation, degeneration or paralysis may result in the need to protect the cornea from exposure or repeated irritation. 2) For corneal pain relief in conditions such as bullous keratopathy, epithelial erosion and abrasion, filamentary keratitis, and post-keratoplasty. 3) For use as a barrier during the healing process of epithelial defects such as chronic epithelial defects, corneal ulcer, neurotrophic and neuroparalytic keratitis, and chemical burns. 4) For post surgical conditions where bandage lens use is indicated such as post refractive surgery, lamellar grafts, corneal flaps, and additional ocular surgical conditions. 5) For structural stability and protection in piggy back lens fitting where the cornea and associated surfaces are too irregular to allow for corneal rigid gas permeable (RGP) lenses to be fit. In addition the use of the lens can prevent irritation and abrasions in conditions where there are elevation differences in the host/graph junction or scar tissue. Lenses prescribed for therapeutic use may be worn for daily or extended wearing periods. |
| P040052/S004 8/31/07 Real-Time |
MonoPrep Pap Test | MonoGen, Inc. Lincolnshire, IL 60069 |
Approval for use of reflective white label stock (PN 12358) on all MonoPrep vials, including the MonoPrep Pap Test vial and the Reprocessing vial. |
| P060001/S003 8/2/07 180-Day |
Protégé® GPS and Protégé® RX Carotid Stent System | ev3, Inc. Plymouth, MN 55442 |
Approval of the post-approval study. |
30-Day Notices (135 Day Supplement was not required)
| P790017/S087 8/22/07 |
Sprinter Over the Wire (OTW) Balloon Dilatation Catheter | Medtronic Vascular, Inc. Santa Rosa, CA 95403 |
Adding the option to sterilize the subject device twice. |
| P790017/S088 8/29/07 |
Sprinter Over the Wire (OTW) Balloon Dilatation Catheter and Sprinter Multi-Exchange (MX 2) Balloon Dilatation Catheter | Medtronic Vascular, Inc. Santa Rosa, CA 95403 |
Adding Isotron Ireland, one of Medtronic’s approved contract Ethylene Oxide (EtO) sterilization facilities, to receive, store, and prepare Biological Indicators for routine Sterilization cycles and to complete viability testing. |
| P790017/S091 8/30/07 |
Gruntzig Dilaca Coronary Artery Balloon Dilatation Catheter, NC Stormer MX 2 | Medtronic Vascular, Inc. Santa Rosa, CA 95403 |
Reduction in the number of samples submitted for end of line Quality Control function testing of the device. |
| P790017/S092 8/30/07 |
Gruntzig Dilaca Coronary Artery Balloon Dilatation Catheter, NC Stormer OTW and NC Stormer MX 2 | Medtronic Vascular, Inc. Santa Rosa, CA 95403 |
Reduction in the number of samples submitted for in-process Quality Control tensile testing of the device. |
| P820003/S080 8/10/07 |
Model 5388 External Pulse Generator | Medtronic, Inc. Shoreview, MN 55126 |
Minor modification to a component inspection procedure occurring at a finished device contract manufacturing supplier. |
| P890055/S020 8/23/07 |
Codman 3000 Implantable Infusion Pump Accessory, Barbed Connector (AP-07003) |
Codman & Shurtleff, Inc. Raynham, MA 02767 |
Change 1) in packaging location for the Barbed Catheter Connector to an in-house procedure at Codman & Shurtleff, Raynham, Massachusetts from Avid Medical, Roano, Virginia, and 2) change in the Barbed Catheter Connector packaging to the approved packaging for the Flex 1 Replacement Connector. |
| P900009/S028 8/16/07 |
Exogen 4000+ Sonic Accelerated Fracture Healing System (SAFHS) | Smith & Nephew, Inc. Memphis, TN 38116 |
Change in the manufacture of the Exogen 4000+ device to a continuous flow manufacturing model and a change in the serial numbering scheme of the device. |
| P910023/S144 8/17/07 |
Cadence Implantable Cardioverter Defibrillator (ICD) | St. Jude Medical Cardiac Rhythm Management Sunnyvale, CA 94086 |
Alternate supplier for the Isolation Transformer Module (ITM) and Toroid Inductor used on the high voltage hybrid assembly of the Current™ ICDs and Promote™ CRT-Ds. |
| P910023/S145 8/17/07 |
Cadence Implantable Cardioverter Defibrillator (ICD) | St. Jude Medical Cardiac Rhythm Management Sunnyvale, CA 94086 |
Alternate supplier for the Diode Die, Silicon, 20V, 5%, Zenar Voltage Regulatory, and the Diode Die, High Voltage, High Current components for the device. |
| P910023/S146 8/17/07 |
Cadence Implantable Cardioverter Defibrillator (ICD) | St. Jude Medical Cardiac Rhythm Management Sunnyvale, CA 94086 |
Alternate supplier for the parylene dimer used in the parylene coating for the device. |
| P910073/S067 8/15/07 |
Reliance Active Fix and Reliance Passive Fix Steroid Eluting Endocardial Defibrillation Leads | Guidant Corporation St. Paul, MN 55112 |
Addition of a new piece of inspection equipment for acceptance testing of tubing components. |
| P950005/S021 8/23/07 |
Celsius, Celsius II, Celsius RMT, EZ Steer, EZ Steer DS Diagnostic/Ablation Catheter | Biosense Webster, Inc. Diamond Bar, CA 91745 |
Increasing the sterilization pallet size form a 6-pallet load to a 10-pallet load. |
| P950039/S018 8/30/07 |
ThinPrep® 2000 System | Cytyc Surgical Products Marlborough, MA 01752 |
Approval for a manufacturing site located at Cytyc Corp, Marlborough, Massachusetts. |
| P960028/S023 8/30/07 |
Soft Acrylic Intraocular Lenses (IOLs): Rezoom Multifocal IOLs Model NXG1; Sensar Acrylic IOLs Models: AR40e, AR40M, AR40E, AR40x, and AR40xEM, and Tecnis Acrylic IOL Model ZA9003 | Advanced Medical Optics Santa Ana, CA 92705 |
Addition of an alternate cleaning solvent, Liqui-nox, for the 3-piece soft acrylic intraocular lenses (IOLs) manufactured at the AMO facility in Anasco, Puerto Rico. |
| P970035/S047 8/30/07 |
S-Series Coronary Stent Systems | Medtronic Vascular, Inc. Santa Rosa, CA 95403 |
Reduction in the number of samples which are taken to monitor particulate levels in nitrogen gas and compressed air. |
| P970054/S006 8/24/07 |
Parvovirus B19 IgG Enzyme Immunoassay | Biotrin International LTD Dublin, Ireland |
Change in packaging material. |
| P970055/S006 8/24/07 |
Parvovirus B19 IgM Enzyme Immunoassay | Biotrin International LTD Dublin, Ireland |
Change in packaging material. |
| P980016/S104 8/10/07 |
EnTrust 30J/35J, Virtuoso DR, and Virtuoso VR ICDs | Medtronic, Inc. Shoreview, MN 55126 |
Changes including: 1) moving the accelerometer testing operation earlier in the manufacturing flow; 2) moving the patient alert resting operation earlier in the manufacturing process; and 3) performing the medical adhesive curing and device pre-heat process in a single oven. |
| P980037/S023 8/2/07 |
AngioJet® Rheolytic™ Thrombectomy System | Possis Medical, Inc. Minneapolis, MN 55433 |
Alternate component vendor for the subject device. |
| P980040/S017 8/30/07 |
Soft Acrylic Intraocular Lenses (IOLs): Rezoom Multifocal IOLs Model NXG1; Sensar Acrylic IOLs Models: AR40e, AR40M, AR40E, AR40x, and AR40xEM, and Tecnis Acrylic IOL Model ZA9003 | Advanced Medical Optics Santa Ana, CA 92705 |
Addition of an alternate cleaning solvent, Liqui-nox, for the 3-piece soft acrylic intraocular lenses (IOLs) manufactured at the AMO facility in Anasco, Puerto Rico. |
| P990025/S013 8/23/07 |
Navistar 4 mm Bi-directional Diagnostic/Ablation Catheter | Biosense Webster, Inc. Diamond Bar, CA 91745 |
Increasing the sterilization pallet size form a 6-pallet load to a 10-pallet load. |
| P990080/S026 8/30/07 |
Soft Acrylic Intraocular Lenses (IOLs): Rezoom Multifocal IOLs Model NXG1; Sensar Acrylic IOLs Models: AR40e, AR40M, AR40E, AR40x, and AR40xEM, and Tecnis Acrylic IOL Model ZA9003 | Advanced Medical Optics Santa Ana, CA 92705 |
Addition of an alternate cleaning solvent, Liqui-nox, for the 3-piece soft acrylic intraocular lenses (IOLs) manufactured at the AMO facility in Anasco, Puerto Rico. |
| P000043/S019 8/3/07 |
TherMatrx TMX-3000™ Office Thermotherapy System and TherMatrx® Office Thermotherapy™ System | American Medical Systems Minnetonka, MN 55343 |
Move a manufacturing process from a contract manufacturer in Salt Lake City, Utah, to the final acceptance activity site at American Medical Systems, Minnetonka, Minnesota. |
| P010001/S004 8/17/07 |
Ceramic Transcend Hip Articulation System | CeramTec Ag Plochingen, Germany 73207 |
Implementation of new software to allow polished inserts to be reworked, following inspection, in one of two inner sphere polishing stations. |
| P010031/S072 8/10/07 |
Concerto CRT-Ds | Medtronic, Inc. Shoreview, MN 55126 |
Changes including: 1) moving the accelerometer testing operation earlier in the manufacturing flow; 2) moving the patient alert resting operation earlier in the manufacturing process; and 3) performing the medical adhesive curing and device pre-heat process in a single oven. |
| P010068/S010 8/23/07 |
Navistar RMT DS Catheter | Biosense Webster, Inc. Diamond Bar, CA 91745 |
Increasing the sterilization pallet size form a 6-pallet load to a 10-pallet load. |
| P030005/S044 8/10/07 |
CONTAK RENEWAL TR Family | Guidant Corporation St. Paul, MN 55112 |
Modifications to the clean process recipe for CONTAK RENEWAL TR hybrids. |
| P030009/S009 8/29/07 |
Driver and Rapid Exchange (RX) Coronary Stent Systems | Medtronic Vascular, Inc. Santa Rosa, CA 95403 |
Change of processing additional catheters at the coating stage. |
| P030009/S014 8/30/07 |
Micro-Driver Coronary Stent System (MX 2 and OTW) | Medtronic Vascular, Inc. Santa Rosa, CA 95403 |
Change to the form tool equipment used in the manufacture of the device. |
| P030009/S015 8/30/07 |
Driver and Micro-Driver Coronary Stent Systems | Medtronic Vascular, Inc. Santa Rosa, CA 95403 |
Reduction in the number of samples which are taken to monitor particulate levels in nitrogen gas and compressed air. |
| P030054/S060 8/17/07 |
Epic HF/Atlas Cardiac Resynchronization Therapy Defibrillator (CRT-D) |
St. Jude Medical Cardiac Rhythm Management Sunnyvale, CA 94086 |
Alternate supplier for the Isolation Transformer Module (ITM) and Toroid Inductor used on the high voltage hybrid assembly of the Current™ ICDs and Promote™ CRT-Ds. |
| P030054/S061 8/17/07 |
Epic HF/Atlas Cardiac Resynchronization Therapy Defibrillator (CRT-D) |
St. Jude Medical Cardiac Rhythm Management Sunnyvale, CA 94086 |
Alternate supplier for the Diode Die, Silicon, 20V, 5%, Zenar Voltage Regulatory, and the Diode Die, High Voltage, High Current components for the device. |
| P030054/S062 8/17/07 |
Epic HF/Atlas Cardiac Resynchronization Therapy Defibrillator (CRT-D) |
St. Jude Medical Cardiac Rhythm Management Sunnyvale, CA 94086 |
Alternate supplier for the parylene dimer used in the parylene coating for the device. |
| P050025/S005 8/17/07 |
NexStent Stent and Monorail Delivery System | Boston Scientific Corporation Maple Grove, MN 55311 |
Addition of a second EtO sterilization chamber at the Sterigenics Willowbrook (WB) sterilization facility. |
| P050025/S006 8/24/07 |
NexStent Carotid Stent and Monorail Delivery System | Boston Scientific Corporation Maple Grove, MN 55311 |
Addition of a 100% inspection test to be implemented in receiving inspection and a 100% in-process visual verification to ensure that Connector Blocks properly transmit UV light. |
Summary of PMA Originals & Supplements Approved
Originals: 2
Supplements: 57
Summary of PMA Originals Under Review
Total Under Review: 73
Total Active: 30
Total On Hold: 43
Number Greater Than 180 Days: 4
Summary of PMA Supplements Under Review
Total Under Review: 394
Total Active: 244
Total On Hold: 150
Number Greater Than 180 Days: 19
Summary of All PMA Submissions Received
Originals: 4
Supplements: 122
Summary of PMA Supplement PMA Approval/Denial Decision Times
Number of Approvals: 57
Number of Denials: 0
Average Days Fr Receipt to Decision (Total Time): 256.9
FDA Time: 108.5 Days MFR Time: 148.4 Days
Updated September 18, 2007
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