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
| P050004 5/8/07 |
EMS Swiss Dolorclast® | Electro Medical Systems (EMS) S.A. Nyon , Switzerland CH-1650 |
Approal for the EMS Swiss Dolorclast®. The EMS Swiss Dolorclast® is a non-surgical alternative indicated for the treatment of chronic proximal plantar fasciitis for patients 18 years of age or older with symptoms for 6 months or more and a history of unsuccessful conservative therapy. Chronic proximal plantar fasciitis is defined as heel pain in the area of the insertion of the plantar fascia on the medical calcaneal tuberosity. |
| P060005 5/11/07 |
IMMULITE® / IMMULITE® 1000 and IMMULITE® 2000 Free PSA Assays | Siemens Medical Solutions Diagnostics Los Angeles , CA 90045 |
Approval for the IMMULITE® / IMMULITE® 1000 and IMMULITE® 2000 Free PSA Assay. These devices are indicated for: The IMMULITE® / IMMULITE® 1000 Free PSA Assay is indicated for in vitro diagnostic use with the IMMULITE® / IMMULITE® 1000 Analyzer for the quantitative measurement of free prostate-specific antigen (PSA) not bound to α1-antichymotrypsin or other binding proteins (uncomplexed) in human serum (including serum collected in serum glass, serum plastic an serum gel separator tubes). Measurement of Free PSA is used in conjunction with IMMULITE® / IMMULITE® 1000 Total PSA to determine a ratio of Free PSA to Total PSA (percent Free PSA). The percent Free PSA is used as an aid in discriminating prostate cancer from benign disease in men 50 years or older with IMMULITE® / IMMULITE® 1000 total PSA values between 4 and 10 ng/mL and digital rectal exam (DRE) findings not suspicious of cancer. Prostate biopsy is required for the diagnosis of prostate cancer. The IMMULITE® 2000 Free PSA Assay is indicated for in vitro diagnostic use with the IMMULITE® 2000 Analyzer for the quantitative measurement of free prostate-specific antigen (PSA) not bound to α1-antichymotrypsin or other binding proteins (uncomplexed) in human serum (including serum collected in serum glass, serum plastic an serum gel separator tubes). Measurement of Free PSA is used in conjunction with IMMULITE® 2000 Total PSA to determine a ratio of Free PSA to Total PSA (percent Free PSA). The percent Free PSA is used as an aid in discriminating prostate cancer from benign disease in men 50 years or older with IMMULITE® 2000 total PSA values between 4 and 10 ng/mL and digital rectal exam (DRE) findings not suspicious of cancer. Prostate biopsy is required for the diagnosis of prostate cancer. |
| P060011 5/3/07 |
C-flex™ Model 570C Intraocular Lens (IOL) | Rayner Surgical, Inc. Los Angeles , CA 90042 |
Approval for the C-flex™ Model 570C Intraocular Lens (IOL). The device is indicated for primary implantation for the visual correction of aphakia in adults in whom a cataractous lens has been removed by phacoemulsifica-tion. The lens is intended to be place in the capsular bag. |
| P060034 5/31/07 |
Bio-Rad MONOLISA™ Anti-HBc IgM EIA | Bio-Rad Laboratories Redmond , WA 98052 |
Approval for the Bio-Rad MONOLISA™ Anti-HBc IgM EIA. The device is indicated for: The Bio-Rad MONOLISA™ Anti-HBc IgM EIA is an enzyme immunoassay intended for use in the qualitative detection of IgM antibodies to hepatitis B core antigen (anti-HBc IgM) in human serum or plasma (potassium EDTA, sodium citrate, ACD [acid citrate dextrose], lithium heparin and sodium heparin). Assay results may be used with other HBV serological markers for the laboratory diagnosis of HBV disease associated with HBV infection. |
PMA Supplemental Approvals
| N16895/S089 5/17/07 180-Day |
SofLens® (polymacon) Contact Lens | Bausch & Lomb Rochester , NY 14609 |
Approval for a manufacturing site located at Bausch & Lomb, Porto Alegre, Brazil. |
| P820003/S079 5/3/07 Real-Time |
Software Enhancements to the Medtronic Model 9986 Desktop BOSS (Version 1.6) for the Medtronic Model 2090 CareLink Programmer for all currently approved Medtronic and Vitatron Pacemaker and ICD Models | Medtronic, Inc. Minneapolis , MN 55432 |
Approval for software enhancements to the Medtronic Model 9986 Desktop BOSS (Version 1.6) for the Medtronic Model 2090 CareLink Programmer for all currently approved Medtronic and Vitatron Pacemaker and ICD Models. |
| P830045/S105 5/9/07 135-Day |
Paragon / Phoenix Family of Pacemakers | St. Jude Medical, CRMD Sylmar , CA 91342 |
Approval for alternate automated test equipment (ATE). |
| P830045/S106 5/4/07 135-Day |
Paragon / Phoenix Family of Pacemakers | St. Jude Medical, CRMD Sylmar , CA 91342 |
Approval for alternate automated test equipment (ATE). |
| P830045/S107 5/7/07 Real-Time |
Paragon / Phoenix Family of Pacemakers | St. Jude Medical, CRMD Sylmar , CA 91342 |
Approval for modifications to the Epic and Atlas Families of ICDs and CRT-Ds, including: addition of an over-current protection circuit; added capability for RAM operation with ROM backup with Defibrillation Only (DFO) in the hardware backup mode; addition of daily high-voltage lead impedance measurements; addition of LV ring to RV coil pacing pulse configuration; addition of Ventricular Intrinsic Preference feature; and modifications to programmer software and display enhancements. The devices as modified will be marketed under the trade names Promote CRT-D device model numbers 3107-36 and 3107-30, and Current DR and VR ICD device model numbers 2107-36, 2107-30 and 1107-36, 1107-30, and will be supported by the Model 3650 Merlin PCS with Model 3330 Version 6.0 software. |
| P830045/S108 5/7/07 Real-Time |
Paragon / Phoenix Family of Pacemakers | St. Jude Medical, CRMD Sylmar , CA 91342 |
Approval for the Model 3330 Version 6.1.0 Software for the Model 3650 Merlin Patient Care System and the Model 3307 Version 6.4.0 Software for the Model 3510 Programmer. |
| P830045/S109 5/9/07 180-Day |
Paragon / Phoenix Family of Pacemakers | St. Jude Medical Sunnyvale , CA 94086 |
Approval for the Model 3330 Version6.1.1 Software for the Model 3650 Merlin™ Patient Care System and Model 3307 Version 6.4.1 Software for the Model 3510 Programmer which enables V-V timing, AF Suppression and QuickOpt Timing Cycle Optimization in the Frontier II Model 5586 CRT-P device. The device, as modified, will be marketed under the trade names as specified in the device families and is indicated for rate adaptive pacing, cardioversion and defibrillation and/or treatment of heart failure with cardiac resynchronization therapy. |
| P850051/S065 5/3/07 Real-Time |
Software Enhancements to the Medtronic Model 9986 Desktop BOSS (Version 1.6) for the Medtronic Model 2090 CareLink Programmer for all currently approved Medtronic and Vitatron Pacemaker and ICD Models | Medtronic, Inc. Minneapolis , MN 55432 |
Approval for software enhancements to the Medtronic Model 9986 Desktop BOSS (Version 1.6) for the Medtronic Model 2090 CareLink Programmer for all currently approved Medtronic and Vitatron Pacemaker and ICD Models. |
| P860004/S088 5/1/07 Real-Time |
Intrathecal Catheter Models 8709, 8711, 8709SC, 8731SC, and Revision Kit 8598A | Medtronic Neurological Minneapolis , MN 55432 |
Approval for: 1) a new catheter tip push-out force specification; 2) a modified manufacturing monitoring process to assure conformance to new catheter tip push-out force specification; 3) a change to the catheter tip material for catheter Model 8731SC and revision kit Model 8598A; and 4) labeling revisions. |
| P860019/S217 5/10/07 135-Day |
PTCA Catheters | Boston Scientific Cardiovascular Maple Grove , MN 55311 |
Approval to implement an alternate location for preparation of a hydrophilic coating solution component known as pre-Bioslide and approval for an alternat supplier of the polymer initiator AIBN. |
| P870076/S008 5/24/07 180-Day |
ACMI Falope Ring Band | Gyrus ACMI Corporation Southborough , MA 01772 |
Approval for a manufacturing site located at Gyrus ACMI Corporation, Maple Grove Minnesota to manufacture the Falope Ring Band and the Falope Ring Band Disposable Applicator Kits. |
| P880006/S048 5/9/07 135-Day |
Sensolog / Dialog / Regency Family of Pacemakers | St. Jude Medical, CRMD Sylmar , CA 91342 |
Approval for alternate automated test equipment (ATE). |
| P880006/S049 5/4/07 135-Day |
Sensolog / Dialog / Regency Family of Pacemakers | St. Jude Medical, CRMD Sylmar , CA 91342 |
Approval for alternate automated test equipment (ATE). |
| P880006/S050 5/7/07 Real-Time |
Sensolog / Dialog / Regency Family of Pacemakers | St. Jude Medical, CRMD Sylmar , CA 91342 |
Approval for modifications to the Epic and Atlas Families of ICDs and CRT-Ds, including: addition of an over-current protection circuit; added capability for RAM operation with ROM backup with Defibrillation Only (DFO) in the hardware backup mode; addition of daily high-voltage lead impedance measurements; addition of LV ring to RV coil pacing pulse configuration; addition of Ventricular Intrinsic Preference feature; and modifications to programmer software and display enhancements. The devices as modified will be marketed under the trade names Promote CRT-D device model numbers 3107-36 and 3107-30, and Current DR and VR ICD device model numbers 2107-36, 2107-30 and 1107-36, 1107-30, and will be supported by the Model 3650 Merlin PCS with Model 3330 Version 6.0 software. |
| P880006/S051 5/7/07 Real-Time |
Sensolog / Dialog / Regency Family of Pacemakers | St. Jude Medical, CRMD Sylmar , CA 91342 |
Approval for the Model 3330 Version 6.1.0 Software for the Model 3650 Merlin Patient Care System and the Model 3307 Version 6.4.0 Software for the Model 3510 Programmer. |
| P880006/S052 5/9/07 180-Day |
Sensolog / Dialog / Regency Family of Pacemakers | St. Jude Medical Sunnyvale , CA 94086 |
Approval for the Model 3330 Version6.1.1 Software for the Model 3650 Merlin™ Patient Care System and Model 3307 Version 6.4.1 Software for the Model 3510 Programmer which enables V-V timing, AF Suppression and QuickOpt Timing Cycle Optimization in the Frontier II Model 5586 CRT-P device. The device, as modified, will be marketed under the trade names as specified in the device families and is indicated for rate adaptive pacing, cardioversion and defibrillation and/or treatment of heart failure with cardiac resynchronization therapy. |
| P880086/S140 5/9/07 135-Day |
Affinity / Integrity / Victory Family of Pacemakers | St. Jude Medical, CRMD Sylmar , CA 91342 |
Approval for alternate automated test equipment (ATE). |
| P880086/S141 5/4/07 135-Day |
Affinity / Integrity / Victory Family of Pacemakers | St. Jude Medical, CRMD Sylmar , CA 91342 |
Approval for alternate automated test equipment (ATE). |
| P880086/S142 5/7/07 Real-Time |
Affinity / Integrity / Victory Family of Pacemakers | St. Jude Medical, CRMD Sylmar , CA 91342 |
Approval for modifications to the Epic and Atlas Families of ICDs and CRT-Ds, including: addition of an over-current protection circuit; added capability for RAM operation with ROM backup with Defibrillation Only (DFO) in the hardware backup mode; addition of daily high-voltage lead impedance measurements; addition of LV ring to RV coil pacing pulse configuration; addition of Ventricular Intrinsic Preference feature; and modifications to programmer software and display enhancements. The devices as modified will be marketed under the trade names Promote CRT-D device model numbers 3107-36 and 3107-30, and Current DR and VR ICD device model numbers 2107-36, 2107-30 and 1107-36, 1107-30, and will be supported by the Model 3650 Merlin PCS with Model 3330 Version 6.0 software. |
| P880086/S143 5/7/07 Real-Time |
Affinity / Integrity / Victory Family of Pacemakers | St. Jude Medical, CRMD Sylmar , CA 91342 |
Approval for the Model 3330 Version 6.1.0 Software for the Model 3650 Merlin Patient Care System and the Model 3307 Version 6.4.0 Software for the Model 3510 Programmer. |
| P880086/S145 5/9/07 180-Day |
Affinity / Integrity / Victory / Zephyr Family of Pacemakers | St. Jude Medical Sunnyvale , CA 94086 |
Approval for the Model 3330 Version6.1.1 Software for the Model 3650 Merlin™ Patient Care System and Model 3307 Version 6.4.1 Software for the Model 3510 Programmer which enables V-V timing, AF Suppression and QuickOpt Timing Cycle Optimization in the Frontier II Model 5586 CRT-P device. The device, as modified, will be marketed under the trade names as specified in the device families and is indicated for rate adaptive pacing, cardioversion and defibrillation and/or treatment of heart failure with cardiac resynchronization therapy. |
| P880086/S146 5/9/07 Real-Time |
Affinity / Integrity / Victory / Zephyr Families of Pacemakers | St. Jude Medical CRMD Sunnyvale , CA 95086 |
Approval for the Zephyr XL SR Model 5626 Pacemaker which utilizes the XL battery Model 9438 which is currently approved for use with the marketed Zephyr XL DR 5826 Pacemaker. The device, as modified, will be marketed under the trade name Zephyr XL SR Model 5626 and is indicated for single chamber rate adaptive pacing. |
| P890003/S116 5/4/07 Real-Time |
Carelink Monitor Model 2490C, Model 2491 DDMA and CardioSight Reader Model 220A | Medtronic, Inc. Cardiac Rhythm Disease Management Shoreview , MN 55126 |
Approval for updates to the CareLink v1.1 Device Data Management Application to (1) provide support for Concerto with atrial therapies; (2) allow transmission of an “Alert” signal for AT/AF Burden and Fast V Response observations if there is an associated alert; (3) output the type of episode log for invalid episodes so CareLink can properly display invalid episodes as Arrhythmia Episodes or Ventricular Sensing Episodes; and (4) correct a problem where the Cardiac Compass “Ventricular Rate During AT/AF” graph does not always print the Mean Ventricular Rate. |
| P890003/S117 5/3/07 Real-Time |
Software Enhancements to the Medtronic Model 9986 Desktop BOSS (Version 1.6) for the Medtronic Model 2090 CareLink Programmer for all currently approved Medtronic and Vitatron Pacemaker and ICD Models | Medtronic, Inc. Minneapolis , MN 55432 |
Approval for software enhancements to the Medtronic Model 9986 Desktop BOSS (Version 1.6) for the Medtronic Model 2090 CareLink Programmer for all currently approved Medtronic and Vitatron Pacemaker and ICD Models. |
| P900061/S072 5/3/07 Real-Time |
Software Enhancements to the Medtronic Model 9986 Desktop BOSS (Version 1.6) for the Medtronic Model 2090 CareLink Programmer for all currently approved Medtronic and Vitatron Pacemaker and ICD Models | Medtronic, Inc. Minneapolis , MN 55432 |
Approval for software enhancements to the Medtronic Model 9986 Desktop BOSS (Version 1.6) for the Medtronic Model 2090 CareLink Programmer for all currently approved Medtronic and Vitatron Pacemaker and ICD Models. |
| P910001/S026 5/11/07 180-Day |
Spectranetics CVX-300 Excimer Laser Coronary Angioplasty (ELCA) System | Spectranetics Corp. Colorado Springs , CO 80907 |
Approval for the removal of a coating on the inner lumen of the Extreme catheter model numbers 114-001, 117-002, and 120-001, the change to black tubing for 0.9 mm catheter model numbers 110-003 and 110-004 X-80, and the change in the strain relief material durometer for the 0.9 mm Extreme catheter model numbers 110-001, 110-002, 110-152 and 0.7 mm Extreme catheter model 110-005 to prevent kinking at the strain relief. |
| P910023/S133 5/7/07 Real-Time |
Cadence Family of ICDs | St. Jude Medical, CRMD Sylmar , CA 91342 |
Approval for modifications to the Epic and Atlas Families of ICDs and CRT-Ds, including: addition of an over-current protection circuit; added capability for RAM operation with ROM backup with Defibrillation Only (DFO) in the hardware backup mode; addition of daily high-voltage lead impedance measurements; addition of LV ring to RV coil pacing pulse configuration; addition of Ventricular Intrinsic Preference feature; and modifications to programmer software and display enhancements. The devices as modified will be marketed under the trade names Promote CRT-D device model numbers 3107-36 and 3107-30, and Current DR and VR ICD device model numbers 2107-36, 2107-30 and 1107-36, 1107-30, and will be supported by the Model 3650 Merlin PCS with Model 3330 Version 6.0 software. |
| P910023/S134 5/7/07 Real-Time |
Cadence Family of ICDs | St. Jude Medical, CRMD Sylmar , CA 91342 |
Approval for the Model 3330 Version 6.1.0 Software for the Model 3650 Merlin Patient Care System and the Model 3307 Version 6.4.0 Software for the Model 3510 Programmer. |
| P910023/S138 5/9/07 180-Day |
Cadence Family of ICDs | St. Jude Medical Sunnyvale , CA 94086 |
Approval for the Model 3330 Version6.1.1 Software for the Model 3650 Merlin™ Patient Care System and Model 3307 Version 6.4.1 Software for the Model 3510 Programmer which enables V-V timing, AF Suppression and QuickOpt Timing Cycle Optimization in the Frontier II Model 5586 CRT-P device. The device, as modified, will be marketed under the trade names as specified in the device families and is indicated for rate adaptive pacing, cardioversion and defibrillation and/or treatment of heart failure with cardiac resynchronization therapy. |
| P910077/S073 5/1/07 Real-Time |
LATITUDE Patient Management System Inductive Communicator Software, version 1.3 (Model 6481) | Guidant Corporation Cardiac Rhythm Management St. Paul , MN 55112 |
Approval for: 1) a change to the time base of the Inductive Communicator clock and 2) improvements to telephone detection/disabling of the call-waiting feature and improvement of telephone dial-tone detection. |
| P930022/S005 5/3/07 Real-Time |
Software Enhancements to the Medtronic Model 9986 Desktop BOSS (Version 1.6) for the Medtronic Model 2090 CareLink Programmer for all currently approved Medtronic and Vitatron Pacemaker and ICD Models | Medtronic, Inc. Minneapolis , MN 55432 |
Approval for software enhancements to the Medtronic Model 9986 Desktop BOSS (Version 1.6) for the Medtronic Model 2090 CareLink Programmer for all currently approved Medtronic and Vitatron Pacemaker and ICD Models. |
| P950020/S023 5/10/07 135-Day |
Cutting Balloon | Boston Scientific Cardiovascular Maple Grove , MN 55311 |
Approval to implement an alternate location for preparation of a hydrophilic coating solution component known as pre-Bioslide and approval for an alternat supplier of the polymer initiator AIBN. |
| P960013/S025 5/7/07 180-Day |
OptiSense Model 1699T/TC Leads | St. Jude Medical, CRMD Sylmar , CA 91342 |
Approval for the OptiSense Model 1699T and 1699TC Leads. The device, as modified, will be marketed under the trade name OptiSense Model 1699T and 1699TC Leads and are designed for permanent sensing and pacing in the right atrium, in combination with a compatible pulse generator. An active fixation lead such as the model 1699 may be indicated for patients where permanent fixation of passive leads is suspected to be unstable. In atrial applications, the use of a screw-in lead may be indicated in the presence of an abnormal, surgically altered or excised atrial appendage . |
| P960030/S016 5/9/07 Real-Time |
IsoFlex S Lead Model 1642T | Cardiac Rhythm Management Division Sylmar , CA 91342 |
Approval for modifications to the lead insulation wall thickness and length, as well as a change to the outer coil exit angle. |
| P970003/S081 5/14/07 Special |
VNS Therapy™ System | Cyberonics, Inc. Houston , TX 77058 |
Approval to add additional precautionary information to the Model 300 Lead Physician’s Manual as an errata sheet and to revise the Model 102, 102R, 302 and 303 VNS Therapy Physician’s Manual module entitled “Introduction to the VNS Therapy (System Indications, Contraindications, Warnings, and Precautions).” |
| P970012/S027 5/3/07 Real-Time |
Software Enhancements to the Medtronic Model 9986 Desktop BOSS (Version 1.6) for the Medtronic Model 2090 CareLink Programmer for all currently approved Medtronic and Vitatron Pacemaker and ICD Models | Medtronic, Inc. Minneapolis , MN 55432 |
Approval for software enhancements to the Medtronic Model 9986 Desktop BOSS (Version 1.6) for the Medtronic Model 2090 CareLink Programmer for all currently approved Medtronic and Vitatron Pacemaker and ICD Models. |
| D970012/S038 5/31/07 Real-Time |
The AMS 700™ Series Product Line Inflatable Penile Prosthesis | American Medical Systems, Inc. Minnetonka , MN 55343 |
Approval for the shortening of the Kink Resistant Tubing (KRT) that connects CX and LGX cylinders to the MS Pump™ on preconnected, penoscrotal devices by 0.91 inches. In addition, the overlying ePTFE sleeve length has also been reduced for most cylinder sizes. |
| P970013/S015 5/9/07 135-Day |
Microny Family of Pacemakers | St. Jude Medical, CRMD Sylmar , CA 91342 |
Approval for alternate automated test equipment (ATE). |
| P970013/S016 5/4/07 135-Day |
Microny Family of Pacemakers | St. Jude Medical, CRMD Sylmar , CA 91342 |
Approval for alternate automated test equipment (ATE). |
| P970013/S017 5/7/07 Real-Time |
Microny Family of Pacemakers | St. Jude Medical, CRMD Sylmar , CA 91342 |
Approval for modifications to the Epic and Atlas Families of ICDs and CRT-Ds, including: addition of an over-current protection circuit; added capability for RAM operation with ROM backup with Defibrillation Only (DFO) in the hardware backup mode; addition of daily high-voltage lead impedance measurements; addition of LV ring to RV coil pacing pulse configuration; addition of Ventricular Intrinsic Preference feature; and modifications to programmer software and display enhancements. The devices as modified will be marketed under the trade names Promote CRT-D device model numbers 3107-36 and 3107-30, and Current DR and VR ICD device model numbers 2107-36, 2107-30 and 1107-36, 1107-30, and will be supported by the Model 3650 Merlin PCS with Model 3330 Version 6.0 software. |
| P970013/S018 5/7/07 Real-Time |
Microny Family of Pacemakers | St. Jude Medical, CRMD Sylmar , CA 91342 |
Approval for the Model 3330 Version 6.1.0 Software for the Model 3650 Merlin Patient Care System and the Model 3307 Version 6.4.0 Software for the Model 3510 Programmer. |
| P970013/S019 5/9/07 180-Day |
Microny Family of Pacemakers | St. Jude Medical Sunnyvale , CA 94086 |
Approval for the Model 3330 Version6.1.1 Software for the Model 3650 Merlin™ Patient Care System and Model 3307 Version 6.4.1 Software for the Model 3510 Programmer which enables V-V timing, AF Suppression and QuickOpt Timing Cycle Optimization in the Frontier II Model 5586 CRT-P device. The device, as modified, will be marketed under the trade names as specified in the device families and is indicated for rate adaptive pacing, cardioversion and defibrillation and/or treatment of heart failure with cardiac resynchronization therapy. |
| P970018/S012 5/9/07 Special |
PrepStain™ System | BD Diagnostics Diagnostic Systems, Tripath Durham , NC 27703 |
Approval for labeling changes for extension of the antimicrobial effectiveness of the SurePath® Preservative Fluid to 14 days for E. coli, P. aeruginosa, S. aureus, C. albicans, and A. niger and 28 days for M. tuberculosis. |
| P980016/S096 5/4/07 Real-Time |
Virtuoso Models D154AWG / D154VWC Implantable Cardioverter Defibrillators | Medtronic, Inc. Cardiac Rhythm Disease Management Shoreview , MN 55126 |
Approval for updates to the CareLink v1.1 Device Data Management Application to (1) provide support for Concerto with atrial therapies; (2) allow transmission of an “Alert” signal for AT/AF Burden and Fast V Response observations if there is an associated alert; (3) output the type of episode log for invalid episodes so CareLink can properly display invalid episodes as Arrhythmia Episodes or Ventricular Sensing Episodes; and (4) correct a problem where the Cardiac Compass “Ventricular Rate During AT/AF” graph does not always print the Mean Ventricular Rate. |
| P980016/S098 5/3/07 Real-Time |
Software Enhancements to the Medtronic Model 9986 Desktop BOSS (Version 1.6) for the Medtronic Model 2090 CareLink Programmer for all currently approved Medtronic and Vitatron Pacemaker and ICD Models | Medtronic, Inc. Minneapolis , MN 55432 |
Approval for software enhancements to the Medtronic Model 9986 Desktop BOSS (Version 1.6) for the Medtronic Model 2090 CareLink Programmer for all currently approved Medtronic and Vitatron Pacemaker and ICD Models. |
| P980035/S072 5/3/07 Real-Time |
Software Enhancements to the Medtronic Model 9986 Desktop BOSS (Version 1.6) for the Medtronic Model 2090 CareLink Programmer for all currently approved Medtronic and Vitatron Pacemaker and ICD Models | Medtronic, Inc. Minneapolis , MN 55432 |
Approval for software enhancements to the Medtronic Model 9986 Desktop BOSS (Version 1.6) for the Medtronic Model 2090 CareLink Programmer for all currently approved Medtronic and Vitatron Pacemaker and ICD Models. |
| P980037/S022 5/10/07 Real-Time |
AngioJet® Rheolytic™ Thrombectomy System – Spiroflex® Thrombectomy Set | Possis Medical, Inc. Minneapolis , MN 55433 |
Approval for the Spiroflex Thrombectomy Set. |
| P980050/S027 5/3/07 Real-Time |
Software Enhancements to the Medtronic Model 9986 Desktop BOSS (Version 1.6) for the Medtronic Model 2090 CareLink Programmer for all currently approved Medtronic and Vitatron Pacemaker and ICD Models | Medtronic, Inc. Minneapolis , MN 55432 |
Approval for software enhancements to the Medtronic Model 9986 Desktop BOSS (Version 1.6) for the Medtronic Model 2090 CareLink Programmer for all currently approved Medtronic and Vitatron Pacemaker and ICD Models. |
| P990001/S029 5/3/07 Real-Time |
Software Enhancements to the Medtronic Model 9986 Desktop BOSS (Version 1.6) for the Medtronic Model 2090 CareLink Programmer for all currently approved Medtronic and Vitatron Pacemaker and ICD Models | Medtronic, Inc. Minneapolis , MN 55432 |
Approval for software enhancements to the Medtronic Model 9986 Desktop BOSS (Version 1.6) for the Medtronic Model 2090 CareLink Programmer for all currently approved Medtronic and Vitatron Pacemaker and ICD Models. |
| P990013/S009 5/1/07 135-Day |
Surgical Collamer UV-Absorbing Posterior IOL | STAAR Surgical Monrovia , CA 91016 |
Approval for implementation of the in-process burst testing of pouches used on the Collamer IOLs. |
| P990074/S018 5/17/07 180-Day |
Natrelle Saline-Filled Breast Implants | Allergan Santa Barbara , CA 93111 |
Approval for a trade name change from Inamed Saline-Filled Breast Implants to Natrelle Saline-Filled Breast Implants. The device, as modified, will be marketed under the trade name Natrelle Saline-Filled Breast Implants and is indicated for 1) breast augmentation for women 18 years or older; and 2) breast reconstruction. |
| P990080/S008 5/1/07 135-Day |
CeeOn® and TECNIS® Posterior Chamber Intraocular Lens (IOLs) | Advanced Medical Optics Santa Ana , CA 92705 |
Approval for a change in test method for the IOL pouch. |
| P010015/S027 5/3/07 Real-Time |
Software Enhancements to the Medtronic Model 9986 Desktop BOSS (Version 1.6) for the Medtronic Model 2090 CareLink Programmer for all currently approved Medtronic and Vitatron Pacemaker and ICD Models | Medtronic, Inc. Minneapolis , MN 55432 |
Approval for software enhancements to the Medtronic Model 9986 Desktop BOSS (Version 1.6) for the Medtronic Model 2090 CareLink Programmer for all currently approved Medtronic and Vitatron Pacemaker and ICD Models. |
| P010031/S064 5/4/07 Real-Time |
Concerto Models C154DWK / C164AWK Cardiac Resynchronization Therapy Defibrillators | Medtronic, Inc. Cardiac Rhythm Disease Management Shoreview , MN 55126 |
Approval for updates to the CareLink v1.1 Device Data Management Application to (1) provide support for Concerto with atrial therapies; (2) allow transmission of an “Alert” signal for AT/AF Burden and Fast V Response observations if there is an associated alert; (3) output the type of episode log for invalid episodes so CareLink can properly display invalid episodes as Arrhythmia Episodes or Ventricular Sensing Episodes; and (4) correct a problem where the Cardiac Compass “Ventricular Rate During AT/AF” graph does not always print the Mean Ventricular Rate. |
| P010031/S066 5/3/07 Real-Time |
Software Enhancements to the Medtronic Model 9986 Desktop BOSS (Version 1.6) for the Medtronic Model 2090 CareLink Programmer for all currently approved Medtronic and Vitatron Pacemaker and ICD Models | Medtronic, Inc. Minneapolis , MN 55432 |
Approval for software enhancements to the Medtronic Model 9986 Desktop BOSS (Version 1.6) for the Medtronic Model 2090 CareLink Programmer for all currently approved Medtronic and Vitatron Pacemaker and ICD Models. |
| P020009/S035 5/10/07 135-Day |
Taxus Express 2 Paclitaxel-Eluting Coronary Stent System | Boston Scientific Cardiovascular Maple Grove , MN 55311 |
Approval for an alternate method for loading die temperature, heat time, and production line settings for the distal heat shrink process used in manufacturing of the devices at the Galway, Ireland manufacturing site. |
| P020024/S015 5/3/07 180-Day |
Amplatzer Duct Occluder and 180 Degree Delivery System | AGA Medical Corp. Golden Valley , MN 55427 |
Approval of the revised post-approval study. |
| P020026/S018 5/18/07 180-Day |
CYPHER™ Sirolimus-eluting Coronary Stent | Cordis Corporation Miami Lakes , FL 33014 |
Approval for a manufacturing site located at Cordis de Mexico, Chihuahua, Mexico to manufacture the Over-the-Wire Stent Delivery System (SDS). |
| P020056/S002 5/2/07 180-Day |
Natrelle silicone-Filled Breast Implants | Allergan Santa Barbara , CA 93111 |
Approval for the diphenyl patch design. The device, as modified, will be marketed under the trade name Natrelle Silicone-Filled breast Implants and is indicated for breast augmentation for women at least 22 years old and for breast reconstruction for women of any age. Breast augmentation includes primary breast augmentation to increase the breast size, as well as revision surgery to correct or improve the result of a primary breast augmentation surgery. Breast reconstruction includes primary reconstruction to replace breast tissue that has been removed due to cancer or trauma or that has failed to develop properly due to a severe breast abnormality. Breast reconstruction also includes revision surgery to correct or improve the result of a primary breast reconstruction surgery. |
| P020056/S003 5/17/07 180-Day |
Natrelle Silicone-filled Breast Implants | Allergan Santa Barbara , CA 93111 |
Approval for a trade name change from Inamed Silicone-Filled Breast Implants to Natrelle Silicone-Filled Breast Implants. The device, as modified, will be marketed under the trade name Natrelle Silicone-Filled Breast Implants and is indicated for breast augmentation for women at least 22 years old and for breast reconstruction for women of any age. Breast augmentation includes primary breast augmentation to increase the breast size, as well as revision surgery to correct or improve the result of a primary breast augmentation surgery. Breast reconstruction includes primary reconstruction to replace breast tissue that has been removed due to cancer or trauma or that has failed to develop properly due to a severe breast abnormality. Breast reconstruction also includes revision surgery to correct or improve the result of a primary breast reconstruction surgery. |
| P030002/S008 5/24/07 180-Day |
Crystalens™ Model AT-45 Accommodating Intraocular Lens | Eyeonics, Inc. Aliso Viejo , CA 92656 |
Perform moist heat sterilization in house at Eyeonics’ Rancho Cucamonga facility. |
| P030017/S020 5/29/07 180-Day |
PRECISION™ Spinal Cord Stimulation (SCS) System | Advanced Bionics Sylmar , CA 91342 |
Approval for the ST Linear Lead (Short Tip Linear Lead). |
| P030017/S024 5/14/07 Special |
PRECISION™ Spinal Cord Stimulation (SCS) System | Advanced Bionics Sylmar , CA 91342 |
Approval for an addendum to the Bionic Navigator Software Guide. |
| P030022/S004 5/4/07 135-Day |
REFLECTION Ceramic Acetabular System | Smith & Nephew, Inc. Memphis , TN 38116 |
Approval or the addition of another EtO sterilization process that utilizes a 4 hour EO exposure time compared to the previous 2 hour EO exposure time, as well as a change in the acceptable number of bioindicators to reflect current AAMI standards. |
| P030025/S042 5/10/07 135-Day |
Taxus Express 2 Paclitaxel-Eluting Coronary Stent System | Boston Scientific Cardiovascular Maple Grove , MN 55311 |
Approval to implement an alternate location for preparation of a hydrophilic coating solution component known as pre-Bioslide and approval for an alternat supplier of the polymer initiator AIBN. |
| P030025/S043 5/10/07 135-Day |
Taxus Express 2 Paclitaxel-Eluting Coronary Stent System | Boston Scientific Cardiovascular Maple Grove , MN 55311 |
Approval for an alternate method for loading die temperature, heat time, and production line settings for the distal heat shrink process used in manufacturing of the devices at the Galway, Ireland manufacturing site. |
| P030035/S028 5/7/07 Real-Time |
Frontier / Frontier II Family of CRT-Ps | St. Jude Medical, CRMD Sylmar , CA 91342 |
Approval for modifications to the Epic and Atlas Families of ICDs and CRT-Ds, including: addition of an over-current protection circuit; added capability for RAM operation with ROM backup with Defibrillation Only (DFO) in the hardware backup mode; addition of daily high-voltage lead impedance measurements; addition of LV ring to RV coil pacing pulse configuration; addition of Ventricular Intrinsic Preference feature; and modifications to programmer software and display enhancements. The devices as modified will be marketed under the trade names Promote CRT-D device model numbers 3107-36 and 3107-30, and Current DR and VR ICD device model numbers 2107-36, 2107-30 and 1107-36, 1107-30, and will be supported by the Model 3650 Merlin PCS with Model 3330 Version 6.0 software. |
| P030035/S029 5/7/07 Real-Time |
Frontier / Frontier II Family of CRT-Ps | St. Jude Medical, CRMD Sylmar , CA 91342 |
Approval for the Model 3330 Version 6.1.0 Software for the Model 3650 Merlin Patient Care System and the Model 3307 Version 6.4.0 Software for the Model 3510 Programmer. |
| P030035/S030 5/16/07 |
St. Jude Medical Pacemakers and CRT-Ps | St. Jude Medical, CRMD Sunnyvale , CA 94086 |
Use of second source vendors for several discrete components on the device hybrid. |
| P030035/S031 5/9/07 180-Day |
Frontier / Frontier II Family of CRT-Ps | St. Jude Medical Sunnyvale , CA 94086 |
Approval for the Model 3330 Version6.1.1 Software for the Model 3650 Merlin™ Patient Care System and Model 3307 Version 6.4.1 Software for the Model 3510 Programmer which enables V-V timing, AF Suppression and QuickOpt Timing Cycle Optimization in the Frontier II Model 5586 CRT-P device. The device, as modified, will be marketed under the trade names as specified in the device families and is indicated for rate adaptive pacing, cardioversion and defibrillation and/or treatment of heart failure with cardiac resynchronization therapy. |
| P030039/S004 5/11/07 180-Day |
CoSeal Surgical Sealant (premixed) | Baxter Healthcare Corporation McGaw Park , IL 60085 |
Approval for the addition of the CoSeal Spray delivery System with a spray set and pressure regulator. |
| P030054/S051 5/7/07 Real-Time |
Epic HF / Atlas+ HF Family of CRT-Ds | St. Jude Medical, CRMD Sylmar , CA 91342 |
Approval for modifications to the Epic and Atlas Families of ICDs and CRT-Ds, including: addition of an over-current protection circuit; added capability for RAM operation with ROM backup with Defibrillation Only (DFO) in the hardware backup mode; addition of daily high-voltage lead impedance measurements; addition of LV ring to RV coil pacing pulse configuration; addition of Ventricular Intrinsic Preference feature; and modifications to programmer software and display enhancements. The devices as modified will be marketed under the trade names Promote CRT-D device model numbers 3107-36 and 3107-30, and Current DR and VR ICD device model numbers 2107-36, 2107-30 and 1107-36, 1107-30, and will be supported by the Model 3650 Merlin PCS with Model 3330 Version 6.0 software. |
| P030054/S052 5/7/07 Real-Time |
Epic HF / Atlas+ HF Family of CRT-Ds | St. Jude Medical, CRMD Sylmar , CA 91342 |
Approval for the Model 3330 Version 6.1.0 Software for the Model 3650 Merlin Patient Care System and the Model 3307 Version 6.4.0 Software for the Model 3510 Programmer. |
| P030054/S056 5/9/07 180-Day |
Epic HF / Atlas+ HF Family of CRT-Ds | St. Jude Medical Sunnyvale , CA 94086 |
Approval for the Model 3330 Version6.1.1 Software for the Model 3650 Merlin™ Patient Care System and Model 3307 Version 6.4.1 Software for the Model 3510 Programmer which enables V-V timing, AF Suppression and QuickOpt Timing Cycle Optimization in the Frontier II Model 5586 CRT-P device. The device, as modified, will be marketed under the trade names as specified in the device families and is indicated for rate adaptive pacing, cardioversion and defibrillation and/or treatment of heart failure with cardiac resynchronization therapy. |
| P040016/S020 5/10/07 135-Day |
Liberté MR & OTW Coronary Stent System | Boston Scientific Cardiovascular Maple Grove , MN 55311 |
Approval to implement an alternate location for preparation of a hydrophilic coating solution component known as pre-Bioslide and approval for an alternat supplier of the polymer initiator AIBN. |
| P040016/S021 5/10/07 135-Day |
Taxus Express 2 Paclitaxel-Eluting Coronary Stent System | Boston Scientific Cardiovascular Maple Grove , MN 55311 |
Approval for an alternate method for loading die temperature, heat time, and production line settings for the distal heat shrink process used in manufacturing of the devices at the Galway, Ireland manufacturing site. |
| P040021/S003 5/25/07 180-Day |
SJM Biocor Aortic Valve, SJM Biocor Mitral Valve and SJM Biocor Supra Valve |
St. Jude Medical, Inc. St. Paul , MN 55117 |
Approval for the addition of the 29mm Biocor® Aortic Valve; addition of sizes 25mm and 27mm Bicor® Supra Aortic Valve; a change in the package solution concentration; a reduced pre-implant rinse time; a change in the vale holder and holder handle designs; and additional hemodynamic data for the 27mm Biocor® Mitral Valve. |
| P040022/S003 5/24/07 Real-Time |
AngioLINK Vascular Closure System | Medtronic Vascular Taunton , NA 02780 |
Approval for incorporation of the following processing and material changes to the distal end of the VCS 1000 Dilator: 1) Change in the dilator material from Nylon 11 to Pebax Nylon 4033 for the dilator distal tip and from Nylon 11 to Pebax Nylon 6033 for the dilator distal shaft; 2) Addition of a RF and/or alternative thermal energy source to bond the dilator distal tip to the distal shaft; and 3) Addition of a heat shrink sleeve to enhance the bond between the shaft and the distal tip. |
| P040038/S003 5/10/07 135-Day |
Xact® Carotid Stent System | Abbott Vascular, Inc. Redwood City , CA 94063 |
Approval for changes to the inspections of the stents performed at the facility and by the supplier. |
| P040044/S001 5/16/07 Panel |
Mynx™ Vascular Closure System | AccessClosure, Inc. Mountain View , CA 94043 |
Approval for the Mynx™ Vascular Closure System. The device is indicted 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, 6F, or 7F procedural sheath. |
| P040052/S002 5/25/07 180-Day |
Monoprep Pap Test (MPPT) | Monogen, Inc. Vernon Hills , IL 60061 |
Approval of the post-approval study. |
| P050012/S001 5/31/07 Panel |
STS-7 Continuous Glucose Monitoring System | DexCom, Inc. San Diego , CA 92121 |
Approval for the STS-7 Continuous Glucose Monitoring System (STS-7 System). The device is indicated for the following: The STS-7 Continuous Glucose Monitoring System (STS-7 System) is a glucose-monitoring device indicated for detecting trends and tracking patterns in adults (age 18 and older) with diabetes. The STS-7 System is intended for use by patients at home and in health care facilities. The device is for prescription use only. The STS-7 Continuous Glucose Monitoring System is indicated for use as an adjunctive device to complement, not replace, information obtained from standard home glucose monitoring devices. The STS-7 Continuous Glucose Monitoring System aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments, which may minimize these excursions. Interpretation of the STS-7 System results should be based on the trends and patterns seen with several sequential readings over time. |
| P050012/S010 5/25/07 Real-Time |
DexCom STS System | DexCom, Inc. San Diego , CA 92121 |
Approval for design revisions to the accessory software program to provide additional supplementary information to users on glucose trends and patterns downloaded to the program. The software program, as modified, will be marketed under the trade name DexCon DM2 and is indicated for use by consumers to allow for the transfer of glucose data stored by the DexCom STS System into a personal computer (PC). |
| P050038/S002 5/30/07 180-Day |
AH Absorbable Hemostat (Arista) | Medafor, Inc. Minneapolis , MN 55430 |
Approval for a manufacturing site change located at Surgical Technologies, Inc. (STI), St. Paul, Minnesota. |
30-Day Notices (135 Day Supplement was not required)
| N18286/S016 5/21/07 |
Gelfoam (Absorbable Gelatin) Sterile and Powder | Pfizer, Inc. New York , NY 10017 |
New sterilization equipment with new sterilization patterns. |
| P790007/S018 5/10/07 |
Hancock MO Valved Conduits | Medtronic Heart Valves Santa Ana , CA 92705 |
Change to the supplier of the polypropylene resin used for the injection molding of the final container lids. |
| P860019/S220 5/10/07 |
Maverick 2 Monorail PTCA Catheters | Boston Scientific Corporation Cardiovascular Maple Grove , MN 55311 |
Alternate manufacturing fixture for laser printing information on the device manifold. |
| P880070/S012 5/8/07 |
CeeOn HSM UV Light Absorbing PMMA Anterior Chamber IOLs | Advanced Medical Optics, Inc. Santa Ana , CA 92705 |
Addition of a second ETO sterilizer (GEE 6913 AR-1) used in the sterilization of IOLs manufactured at the AMO Groningen, Netherlands facility. |
| P880086/S144 5/16/07 |
St. Jude Medical Pacemakers and CRT-Ps | St. Jude Medical, CRMD Sunnyvale , CA 94086 |
Use of second source vendors for several discrete components on the device hybrid. |
| P880091/S022 5/16/07 |
STAAR Surgical ELASTIMIDE Ultraviolet-Absorbing Silicone Three Piece Posterior Chamber Intraocular Lens | STAAR Surgical Company Monrovia , CA 91016 |
Implementation of the Rotlex IOLA Plus Optical Test Systems as an additional measuring system for the diopteric power measurement of 3-piece Silicone Intraocular Lenses (IOL) has been reviewed. |
| P910023/S135 5/10/07 |
Cadence Implantable Cardioverter Defibrillator (ICD) | St. Jude Medical, CRMD Sunnyvale , CA 94086 |
Use of an alternate vendor for the ICD/CRT-D septum material. |
| P910023/S137 5/16/07 |
St. Jude Medical ICDs and CRT-Ds | St. Jude Medical, CRMD Sunnyvale , CA 94086 |
Use of second source vendors for several discrete components on the device hybrid. |
| P910023/S139 5/23/07 |
Epic Family of ICDs | St. Jude Medical, CRMD Sunnyvale , CA 94086 |
Changes to the Epic ICD and CRT-D Self-test manufacturing software test method. |
| P930038/S050 5/4/07 |
Angio-Seal™ Vascular Closure Device | St. Jude Medical, Inc. Maple Grove , MN 55330 |
Changes to the scheduling of the Lot Release Deployment test for Angio-Seal™ Vascular Closure Device. |
| P960034/S002 5/8/07 |
CeeOn Heparin Surface Modified (HSM) UV Light-Absorbing Posterior Chamber IOLs | Advanced Medical Optics, Inc. Santa Ana , CA 92705 |
Addition of a second ETO sterilizer (GEE 6913 AR-1) used in the sterilization of IOLs manufactured at the AMO Groningen, Netherlands facility. |
| P970003/S080 5/10/07 |
NCP Programming Wands, Model 201 | Cyberonics, Inc. Houston , TX 77058 |
Modify the current manufacturing process of the NCP Programming Wands, Model 201 by adding an automated version of the final electrical test process. |
| D970012/S037 5/3/07 |
AMS 700™ Series Inflatable Penile Prosthesis | American Medical Systems, Inc. Minnetonka , MN 55343 |
Conversion of an in-process inspection test from mandatory to optional. |
| P980049/S026 5/18/07 |
Ovatio DR 6550 and Ovatio VR 6250 Implantable Cardioverter Defibrillators (ICDs) | ELA Medical, Inc Plymouth , MN 55441 |
Change in the flux used for solder rework. |
| P990080/S023 5/8/07 |
Foldable Ultraviolet Light (UV) Absorbing Posterior Chamber IOLs, CeeOn Models 911A and 913A, and Tecnis Models 29000 and Z9001 | Advanced Medical Optics, Inc. Santa Ana , CA 92705 |
Addition of a second ETO sterilizer (GEE 6913 AR-1) used in the sterilization of IOLs manufactured at the AMO Groningen, Netherlands facility. |
| P000029/S030 5/1/07 |
Deflux® Injectable Gel | Q-MED Scandinavia, Inc. Princeton , NJ 08540 |
Change in the method of managing materials in the Q-MED AB warehouse. |
| P020004/S021 5/4/07 |
Gore Excluder® AAA Endoprosthesis | W.L. Gore & Associates, Inc. Flagstaff , AZ 86003 |
Change of the graft attach procedure from a manual process to an automated process. |
| P020026/S034 5/4/07 |
Cordis CYPHER® Sirolimus-eluting Coronary Stent | Cordis Corporation Miami , FL 33102 |
Change to the balloon wall irregularity inspection criteria. |
| P020055/S001 5/16/07 |
PATHWAY® Anti-C Kit (9.7) Primary Antibody |
Ventana Medical Systems, Inc. Tucson , AZ 85737 |
Change of system operating software from DOS to Windows for the Drop Volume Tester Computer Workstation Hardware. |
| P030002/S011 5/25/07 |
Crystalens™ Model AT-45 Accommodating Intraocular Lens | Eyeonics, Inc. Aliso Viejo , CA 92656 |
Change in the tumbling and pre-cleaning process for the device. |
| P030011/S002 5/23/07 |
CardioWest™ Temporary Total Artificial Heart (TAH-t) System | SynCardia Systems, Inc. Tucson , AZ 85713 |
Use of a larger sterilization chamber to sterilize the device. |
| P030053/S001 5/17/07 |
Mentor Memory Gel Silicone Gel-Filled Breast Implants | Mentor Corporation Santa Barbara , CA 93111 |
Approval of the post-approval study. |
| P030054/S053 5/10/07 |
Epic HF Cardiac Resynchronization Therapy defibrillator (CRT-D) | St. Jude Medical, CRMD Sunnyvale , CA 94086 |
Use of an alternate vendor for the ICD/CRT-D septum material. |
| P030054/S055 5/16/07 |
St. Jude Medical ICDs and CRT-Ds | St. Jude Medical, CRMD Sunnyvale , CA 94086 |
Use of second source vendors for several discrete components on the device hybrid. |
| P030054/S057 5/23/07 |
Epic Family of CRT-Ds | St. Jude Medical, CRMD Sunnyvale , CA 94086 |
Changes to the Epic ICD and CRT-D Self-test manufacturing software test method. |
| P040002/S012 5/18/07 |
Powerlink System with Visiflex Delivery Catheter System | Endologix, Inc. Irvine , CA 92618 |
Change of vendors for the obturator component of the inner core subassembly of the 19Fr straight Visiflex delivery system. |
| P040012/S026 5/2/07 |
ACCULINK and RX ACCULINK Carotid Stent System | Abbott Vascular, Inc. Santa Clare , CA 95054 |
Change to the stent deployment force lot release test method. |
| P040024/S006 5/2/07 Panel |
Perlane Injectable Gel | Medicis Aesthetics Holdings, Inc Scottsdale , AZ 5258 |
Approval for the Perlane Injectable Gel. The device is indicated for implantation into the deep dermis to superficial subcutis for the correction of moderate to severe facial folds and wrinkles, such as nasolabial folds. |
| P040027/S004 5/2/07 |
Gore VIATORR® TIPS Endoprosthesis | W.L. Gore & Associates, Inc. Flagstaff , AZ 86003 |
Retrofit existing manufacturing equipment with computer-controlled hardware. |
| P040037/S005 5/2/07 |
Gore VIABAHN® Endoprosthesis | W.L. Gore & Associates, Inc. Flagstaff , AZ 86003 |
Retrofit existing manufacturing equipment with computer-controlled hardware. |
| P040047/S002 5/17/07 |
BioForm Medical Coaptite® Injectable Implant | BioForm Medical, Inc. San Mateo , CA 94402 |
New supplier of glycerin, a raw material used in the manufacture of Coaptite®. |
| P050006/S003 5/18/07 |
GORE HELEX Septal Occluder | W.L. Gore & Associates, Inc. Flagstaff , AZ 86003 |
Modification of the destructive testing procedure for the nitinol wire used in the manufacture of the device. |
| P050025/S003 5/10/07 |
NexStent Carotid Stent and Monorail Delivery System | Boston Scientific Cardiovascular Maple Grove , MN 55311 |
Addition of an inspection procedure and a new visual standard that will be implemented as part of routine receiving and inspection for a subassembly used with the NexStent Carotid Stent System. |
| P050037/S001 5/2/07 |
Radiesse Injectable Calcium Hydroxylapatite Implant for soft tissue augmentation for the treatment of facial lipatrophy | BioForm Medical, Inc. Franksville , WI 53126 |
Change in the supplier of a raw material. |
| P050052/S002 5/2/07 |
Radiesse Injectable Calcium Hydroxylapatite Implant for soft tissue augmentation for the treatment of nasolabial folds | BioForm Medical, Inc. Franksville , WI 53126 |
Change in the supplier of a raw material. |
Summary of PMA Originals & Supplements Approved
Originals: 4
Supplements: 84
Summary of PMA Originals Under Review
Total Under Review: 76
Total Active: 24
Total On Hold: 52
Number Greater Than 180 Days: 2
Summary of PMA Supplements Under Review
Total Under Review: 436
Total Active: 255
Total On Hold: 181
Number Greater Than 180 Days: 18
Summary of All PMA Submissions Received
Originals: 1
Supplements: 112
Summary of PMA Supplement PMA Approval/Denial Decision Times
Number of Approvals: 84
Number of Denials: 0
Average Days Fr Receipt to Decision (Total Time): 116.1
FDA Time: 80.3 Days MFR Time: 35.8 Days
Updated November 14, 2007
CDRH Home Page | CDRH A-Z Index | Contact CDRH | Accessibility | Disclaimer
FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA | HHS Home Page
Center for Devices and Radiological Health / CDRH
