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PMA Final Decisions Rendered for May 2000 |
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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 | |||
APPLICATION NUMBER / DATE of APPROVAL | DEVICE TRADE NAME | COMPANY NAME | DEVICE DESCRIPTION / INDICATIONS |
|
5/26/00 |
FocalSeal-L Synthetic Absorbable Sealant |
Focal, Inc. Lexington, MA 02173 |
The FocalSeal-L Synthetic Absorbable Sealant is indicated for use as an adjunct to standard closure of visceral pleural air leaks incurred during elective pulmonary resection. |
|
5/12/00 |
OxiFirst™ Fetal Oxygen Saturation Monitoring System |
Nellcor Puritan Bennett Pleasanton, CA 94588 |
The Nellcor N-400 Fetal Oxygen Saturation Monitoring System (OxiFirst™ System) is indicated to continuously monitor intrapartum fetal oxygen saturation (FspO2). Use of the OxiFirst™ system is indicated as an adjunct to fetal heart rate (FHR) monitoring in the presence of a nonreassuring fetal heart rate pattern. It should only be used after maternal membranes have ruptured and on a singleton fetus in vertex presentation with a gestational age greater than or equal to 36 weeks. |
|
5/31/00 |
Stockert 70 RF Generator for Cardiac Ablation |
Biosense Webster, Inc. Diamond Bar, CA 91765 |
The Stockert 70 RF Generator System is indicated for use with a Biosense Webster Diagnostic/Ablation Deflectable Tip Catheter to deliver RF energy during cardiac ablation procedures. |
|
5/10/00 |
McGhan Medical RTV Saline-Filled Breast Implant |
McGhan Medical Corporation Santa Barbara, CA 93111 |
The McGhan RTV Saline-Filled Breast Implant is indicated for: (1) breast augmentation for women 18 years or older and (2) breast reconstruction. |
|
5/10/00 |
Mentor Corporation Saline-Filled and Spectrum® Mammary Prostheses |
Mentor Corporation Santa Barbara, CA 93111 |
The Mentor Corporation Saline-Filled and Spectrum® Mammary Prostheses are indicated for: (1) breast augmentation for women 18 years of older and (2) breast reconstruction. |
| APPLICATION NUMBER / DATE of APPROVAL | DEVICE TRADE NAME | COMPANY NAME CITY, STATE, & ZIP | DEVICE DESCRIPTION / INDICATIONS |
|
N50510/S130 5/18/00 180-Day |
Vitek® 2 Gram Negative Susceptibility Test for Cefepime |
BioMerieux, Inc. Hazelwood, MO 63042 |
Approval for the addition of the antibiotic cefepime at concentrations of 2, 8, 16 and 32 micrograms/ml to the Vitek® 2 Gram Negative Susceptibility Test System for use in the Vitek® 2 System. |
|
D970003/S010 5/18/00 |
PULSAR™/PULSAR MAX™ Pacemaker System |
Guidant Corporation St. Paul, MN 55112-5798 |
Approval for the Model 2920 Zoom Programming System |
|
P790005/S042 5/10/00 Real-Time |
OsteoGen™ D40 Implantable Bone Growth Stimulator |
EBI, L.P. Parsippany, NJ 07054 |
Approval for a two lead OsteoGen™ Implantable Bone Growth Stimulator. |
|
P810002/S051 5/5/00 Real-Time |
St. Jude Medical® Mechanical Heart Valve – Master Series Coated Aortic Valved Graft (Model CAVGJ-514) |
St. Jude Medical, Inc. St. Paul, MN 55117 |
Approval for a change to the method of forming the vascular graft taper and an increase in the sewing cuff fabric diameter per valve graft size. |
|
P830055/S073 5/19/00 Real-Time |
LCS Total Knee System |
DePuy Orthopaedics, Inc. Warsaw, IN 46581 |
Approval for design modifications to the LCS Total Knee System Femoral Components. |
|
P830060/S048 5/30/00 Real-Time |
Model 6577 Sterilizable Telemetry Wand |
Guidant Corporation St. Paul, MN 55112 |
Approval for the Model 6577 Sterilizable Telemetry Wand. |
|
P840068/S039 5/18/00 180-Day |
DELTA® Pacemaker System |
Guidant Corporation Cardiac Rhythm Management St. Paul, MN 55112 |
Approval for the Model 2920 ZOOM Programming System. |
|
P850007/S025 5/31/00 180-Day |
Physio-Stim® Lite Spinal Fusion System, Model 215L |
Orthofix, Inc. Richardson, TX 75081 |
Approval to modify the Physio-Stim, Model 721 as follows: 1) combine the transducer and control units into a single unit; 2) power the device with one 9-volt disposable battery rather than a multiple cell Ni-Cad Battery Pack with charger unit; 3) based on the above changes, reduce the weight and overall dimensions of the device; 4) indicate the operating status of the device with three LED signal lights rather than an LCD readout; and 5) control power to the device with an on/off button rather than an on/off switch. |
|
P850079/S034 5/5/00 180-Day |
Methafilcon A Contact Lenses |
CooperVision Scottsville, NY 14546 |
Approval of a protocol to extend the shelf life of methafilcon A blister packaged products from 3 years to 6 years. |
|
P890012/S005 5/2/00 180-Day |
GentleTouch™ (netrafilcon A) Extended Wear Soft (Hydrophilic) Contact Lens |
Wesley Jessen Corporation Des Plaines IL 60018 |
Approval for the manufacturing site transfer to Wesley Jessen Inc., Cidra, Puerto Rico, 00739. |
|
P900009/S010 5/10/00 Real-Time |
Exogen 2000® Sonic Accelerated Fracture Healing System |
Exogen Piscataway, NJ 08855 |
Approval for a change in the wording of the indication statement to include the device trade names. |
|
P900023/S032 5/12/00 Special |
ABIOMED® BVS 5000 Bi-Ventricular Support System |
ABIOMED, Inc Danvers, MA 01923 |
Approval for the Instructions for Use for the BVS 5000 Cannulae that were modified to address specific concerns associated with the Hemashield graft and the silicone-coated graft. |
|
P900043/S020 5/11/00 180-Day |
BX VELOCITY™ Stent with Raptor Over-the-Wire Delivery System |
Cordis Corporation Warren, NJ 07059 |
Approval for a modified stent system. |
|
P900043/S023 5/24/00 180-Day |
PALMAZ-SCHATZ® MiniCrown Balloon-Expandable Stent with Dynasty™ Over-the-Wire Delivery System |
Cordis Corporation Warren, NJ 07059 |
Approval for modifications to the labeling for the PALMAZ-SCHATZ® MiniCrown Balloon-Expandable Stent with Dynasty™ Over-the-Wire Delivery System to include 6-month data. |
|
P900056/S033 5/30/00 180-Day |
Rotablator® Rotational Angioplasty System |
Boston Scientific Corporation Northwest Redmond, WA 98052 |
Approval for a labeling change to clarify the apparent absence of the catheter connector. |
|
P910077/S031 5/18/00 180-Day |
VENTAK® PRx AICD™ System |
Guidant Corporation Cardiac Rhythm Management St. Paul, MN 55112 |
Approval for the Model 2920 ZOOM Programming System. |
|
P930031/S007 5/4/00 180-Day |
Wallstent® TIPS (Transjugular Intrahepatic Portosystemic Shunt) Endoprosthesis |
Boston Scientific Corporation Plymouth, MN 55442 |
Approval for adding a reduced profile Unistep™ Plus delivery system for 10 mm diameter stents. |
|
P940019/S005 5/5/00 180-Day |
WALLSTENT® ILIAC Endoprosthesis and Unistep Plus Delivery System |
Boston Scientific Corporation Plymouth, MN 55442 |
Approval for adding a reduced profile Unistep Plus delivery system for 10 mm diameter stents. |
|
P940031/S023 5/18/00 180-Day |
Vigor® DR/SR Pacemaker System |
Guidant Corporation Cardiac Rhythm Management |
Approval for the Model 2920 ZOOM Programming System. |
|
P950001/S004 5/10/00 180-Day |
Atrial J SELUTE PICOTIP® Steroid Eluting Pacing Lead, Models 4063 and 4064 |
Guidant Corporation St. Paul, MN 55112 |
Approval for the Atrial J SELUTE PICOTIP® Steroid Eluting Pacing Lead, Models 4064 and 4064. |
|
P950001/S006 5/19/00 Real-Time |
SELUTE® and SELUTE® PICOTIP™ Bipolar Endocardial Leads, Models 4285, 4033, 4034, and 4035 |
Guidant Corporation St. Paul, MN 55112 |
Approval for: 1) use of a new mechanically interlocking component design to connect the terminal pin to the terminal ring, and 2) use of a shorter IS-1 connector terminal. |
|
P950005/S008 5/30/00 180-Day |
CELSIUS™ Temperature Cables |
Biosense Webster, Inc. Diamond Bar, CA 91765 |
Approval for an alternate manufacturing facility located at Biosense Webster, Inc., Cordis de Mexico, Chihuahua, Mexico. |
|
P950029/S006 5/18/00 180-Day |
Talent Rate Responsive Pacemaker Models DR213, DR223, and SR113; the Opus G Rate Responsive Pacemaker Models 4621 and 4624; and the CSO 4.12 Programming Software |
ELA Medical Plymouth, MN 55441 |
Approval for the introduction of Talent Rate Responsive Pacemaker Models DR213, DR223, and SR113; the Optus G Rate Responsive Pacemaker Models 4621 and 4624; and the CSO 4.12 Programming Software. |
|
P950032/S010 5/3/00 180-Day |
Apligraf (Graftskin) |
Organogenesis, Inc. Canton, MA 02021 |
Approval for a change in the source and composition of the Apligraf growth media. |
|
P950039/S006 5/25/00 180-Day |
ThinPrep® 3000 Processor (TP-3000) |
Cytyc Corporation Boxborough, MA 01719 |
Approval for a second generation model of TP-2000 that has the capability of automatically preparing up to 80 cytology specimens. |
|
P960007/S014 5/19/00 180-Day |
Transcyte™ |
Advanced Tissue Sciences La Jolla, CA 92037 |
Approval to conduct the final product sterility test in-house under the conditions of an isolator environment. |
|
P960040/S013 5/18/00 180-Day |
VENTAK AV AICD System |
Guidant Corporation Cardiac Rhythm Management St. Paul, MN 55112 |
Approval for the Model 2920 ZOOM Programming System. |
|
P960043/S022 5/19/00 Real-Time |
The Closer™ Suture Mediated Closure (SMC) Device and Accessories |
Perclose, Inc. Redwood City, CA 94063 |
Approval for a modification to the mechanism for foot deployment and foot parking of The Closer™ SMC Device. |
|
P960043/S023 5/19/00 180-Day |
The Closer Suture Mediated Closure (SMC) Device and Accessories |
Perclose, Inc. Redwood City, CA 94063 |
Approval for a manufacturing modification to the Snared Knot Pusher, and accessory of The Closer SMC Device. |
|
P960043/S024 5/19/00 180-Day |
The Closer™ Suture Mediated Closure (SMC) Device and Accessories |
Perclose, Inc. Redwood City, CA 94063 |
Approval for a modification to the marker tube of The Closer™ SMC Device. |
|
P960047/S002 5/1/00 Real-Time |
Osteonics and Trident Constrained Acetabular Inserts |
Howmedica Osteonics Rutherford, NJ 07070 |
Approval for the addition of the Trident Constrained Acetabular insert design, and the Modified PCA Co Cr, Modified V40 Co Cr, PCA CoCr+15 mm, PCA Zirconia and V40 Zirconia Femoral Heads to the Osteonics Constrained Acetabular Insert PMA. |
|
P970020/S022 5/16/00 180-Day |
ACS MULTI-LINK RX TRISTAR™ and ACS MULTI-LINK OTW TRISTAR™ Coronary Stent Systems |
Guidant Corporation Temecula, CA 92591 |
Approval for an alternate manufacturing facility located at Guidant Corporation,County Tipperary, Ireland and an alternate sterilization facility located at AEA Technology, Oxfordshire, United Kingdom. |
|
P970033/S002 5/3/00 180-Day |
TransScan T-Scan 2000 |
TransScan, Inc. Ramsey, NJ 07446 |
Approval of a protocol for a postapproval study to examine the effects of the menstrual cycle on the results of the device. |
|
P970035/S017 5/9/00 180-Day |
Medtronic AVE (AVE) S660 with Discrete Technology™ Over-the-Wire and Rapid Exchange Coronary Stent Systems |
Medtronic AVE, Inc. Santa Rosa, CA 95403 |
Approval for the Medtronic AVE (AVE) S660 with Discrete Technology™ Over-the-Wire and Rapid Exchange Coronary Stent Systems. |
|
5/9/00 Panel Track |
LADAR Vision® Excimer Laser System |
Autonomous Technologies Corporation Orlando, FL 32826 |
Approval for the LADARVision® Excimer Laser System indicated for laser in-situ keratomileusis (LASIK). |
|
P970058/S007 5/16/00 180-Day |
ImageChecker M1000 |
R2 Technology, Inc. Los Altos, CA 94022 |
Approval for a change in labeling with respect to efficacy. |
|
P980001/S006 5/24/00 180-Day |
NIROYAL™ Advance Premounted Stent System |
Boston Scientific Corporation 01760 |
Approval for the NIROYAL™ Advance Premounted Stent System. |
|
P980023/S003 5/1/00 180-Day |
Phylax Implantable Cardioverter Defibrillator (ICD) System |
Biotronik, Inc. Lake Oswego, OR 97035 |
Approval for: 1) the introduction of Patient Data Manager Software, PDM 2000, and 2) a new method for determining the Use Before Date of Biotronik’s ICDs. |
|
P980035/S007 5/11/00 Real-Time |
Kappa SR Model 706 |
Medtronic, Inc. Minneapolis, MN 55432 |
Approval for a modification to header part number 149422 for use with the Kappa SR Model 706. |
|
P980049/S001 5/18/00 180-Day |
Defender™ IV DR Model 612, Implantable Cardioverter-Defibrillator |
ELA Medical, Inc. Plymouth, MN 55441 |
Approval for Defender™ IV DR Model 612 |
|
P990023/S001 5/19/00 Real-Time |
Cellugel® Ophthalmic Viscosurgical Device |
Alcon Laboratories, Inc. Fort Worth, TX 76134 |
Approval for changing the finished product’s pH release specification. |
| 30-DAY NOTICES (135 Day Supplement Was Not Required) | |||
| APPLICATION NUMBER & LTR DATE | DEVICE TRADE NAME | COMPANY NAME CITY, STATE, & ZIP | COMMENTS |
|
P900056/S044 5/15/00 |
Rotablator Rotational Angioplasty System |
Boston Scientific Corporation Redmond, WA 98052 |
Modification to the release criteria for sterile loads by removing the Product Verification Testing after sterilization. |
|
P960011/S005 5/19/00 |
BioLon™ 1% Sodium Hyaluronate |
Bio-Technology General Corporation Iselin, NJ 08830 |
Sterility release will be based on review of documentation of the ethylene oxide sterilization cycle and testing of the biological indicators and the external sterility testing of Biolon Syringe surfaces will be discontinued. |
|
P970035/S019 5/11/00 |
S670 with Discrete Technology™ Over the Wire Coronary Stent System |
Medtronic AVE Santa Rosa, CA 95403 |
The three-step manufacturing process of the distal and intermediate tubing will be reduced to a two-step process. |
|
P970035/S020 5/16/00 |
S670 with Discrete Technology Over-the-Wire and Rapid Exchange Coronary Stent Systems |
Medtronic AVE, Inc. Santa Rosa, CA 95403 |
Modification to the electropolish process. |
|
P980001/S019 5/30/00 |
NIR® w/SOX™ Premounted Stent Delivery Systems |
Boston Scientific Scimed, Inc. Maple Grove, MN 55311 |
Minor modification to an in-process manufacturing step for the balloon component of the NIR™ w/SOX™ Premounted Stent Delivery System. |
Summary of PMA Originals & Supplements Approved
Originals: 5
Supplements: 40
Summary of PMA Originals Under Review Summary of PMA Supplements Under Review Summary of All PMA Submissions Received Summary of PMA Supplement PMA Approval/Denial Decision Times Filing to Approval: CDRH Home Page | CDRH A-Z Index | Contact CDRH | Accessibility | Disclaimer Center for Devices and Radiological Health / CDRH
Total Under Review: 82
Total Active: 35
Number Greater Than 180 Days: 1
Total Under Review: 191
Total Active: 117
Total On Hold: 74
Number Greater Than 180 Days: 4
Originals: 1
Supplements: 44
Number of Approvals: 40
Number of Denials: 0
Average Days Fr Receipt to Decision (Total Time): 129.7
FDA Time: 111.8 Days
MFR Time: 16.2 Days
Updated 1/17/2001
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