FDA
Home Page | CDRH Home Page | Search
| CDRH
A-Z Index | Contact CDRH
|
PMA Final Decisions Rendered for February 1998 |
APPLICATION NUMBER/ DATE of APPROVAL | DEVICE TRADE NAME | COMPANY NAME CITY, STATE, & ZIP | DEVICE DESCRIPTION/ INDICATIONS |
---|---|---|---|
P970052
2/20/98 |
FACT, ARC LYNX and Guardian | CardioVascular Dynamics, Inc.
Irvine, CA 92618 |
Approval for the FACT, ARC, LYNX and Guardian Balloon Coronary Dilatation Catheters. These devices are indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion. The application includes authorization from Endosonics Corp., Rancho Cordova, CA, to incorporate information contained in its approved premarket approval application and related supplements for the Cathscanner® Oracle® Micro PTCA Catheter. |
PMA SUPPLEMENTAL APPROVALS | |||
---|---|---|---|
APPLICATION NUMBER/ DATE of APPROVAL | DEVICE TRADE NAME | COMPANY NAME CITY, STATE, & ZIP | DEVICE DESCRIPTION/ INDICATIONS |
N80023/S001
2/20/98 |
Keoflo 7136 Absorbable Glove Dusting Powder (U.S.P.) | Roquette America
Washington, DC 20001 |
Approval for a change to the manufacturing process. |
*P790017/S064 | USCI® Telescope Balloon Dilatation Catheter with Hydro/Pel® Coating | C.R. Bard, Inc.
Billerica, MA 01821 |
Approval to sell the USCI® Telescope Balloon Dilatation
Catheter with Hydro/Pel® Coating to Cordis Corporation for distribution. |
P810055/S066
2/2/98 |
Anterior and Posterior Chamber Intraocular Lenses (IOLS) | Pharmacia & Upjohn, Inc.
Pickerington, OH 43147 |
Approval for the use of an alternate sterilizer at the manufacturing site in Groningen, The Netherlands. |
P830055/S053
2/12/98 |
new jersey LCS® Total Knee System | DePuy, Inc.
Warsaw, IN 46581-0988 |
Approval for gas plasma sterilization of the textured rotating patella components of the new jersey LCS® Total Knee System. |
P860003/S029
2/26/98 |
THERAKOS UVAR® Photopheresis System | THERAKOS | Approval for Griffith Micro Science in Glens Falls, New York, to serve as the contract sterilization facility for the sterilization of the TK001 Photopheresis Procedural Kit, which is validated utilizing a biological indicator system internal to the product. |
P860022/S049
2/6/98 |
BOSTON EQUALENS (itafluorofocon A) and EQUALENS II (oprifocon A) Rigid Gas Permeable Contact Lenses | Polymer Technology Corp.
Rochester, NY 14692 |
Approval for one additional finishing laboratory to become an additional manufacturer and distributor of the contact lenses. The laboratory to be added is Gelflex Laboratories, 3 Hutton Street, Osborne Park, Perth, Western Australia 60017. |
*P880031/S012
2/19/98 |
AMO® VITRAX® Viscoelastic Solution | Allergan Medical Optics
Irvine, CA 92623-9534 |
Approval for a modification to final product release testing requirements for AMO® VITRAX®. |
P880047/S005
2/9/98 |
INTERCEED* (TC7) | Ethicon, Inc.
Somerville, NJ 08876 |
Approval for 1)the addition of an alternate 60 denier yarn constructed of 24 filaments instead of 18 filaments, and 2) the addition of the alternate final product release site of Somerville, New Jersey. The device, as modified, will be marketed under the trade name INTERCEED* (TC7) and is indicated as an adhesion barrier to be used as an adjuvant to gynecologic pelvic surgery. |
P880070/S007
2/2/98 |
Anterior and Posterior Chamber Intraocular Lenses (IOLS) | Pharmacia & Upjohn, Inc.
Pickerington, OH 43147 |
Approval for the use of an alternate sterilizer at the manufacturing site in Groningen, The Netherlands. |
P890025/S010
2/13/98 |
TDx®/TDxFLx® Cyclosporine Monoclonal Whole Blood Assay | Abbott Diagnostic Division, Abbott Laboratories
Abbott Park, IL 60064-3500 |
Approval for change in monoclonal antibody manufacturing site from Sandoz Pharmaceuticals AG., Switzerland to Abbott Laboratories, Abbott Park, IL USA, under the trade name TDx®/TDxFLx® Cyclosporine Monoclonal Whole Blood Assay, It is indicated for the quantitative measurement of cyclosporine as an aid in the management of cardiac, liver, and renal transplant patients. |
P900023/S026
2/2/98 |
BVS 5000 Bi-Ventricular Support System | ABIOMED, Inc.
Danvers, MA 01923 |
Approval to change the current BVS battery to a Hawker Genesis HrD 13 Ah battery, Model G12V13Ah10EP. |
P900056/S023
2/23/98 |
Rotablator® Rotational Angioplasty System | Boston Scientific Corporation
Redmond, WA 98052-3376 |
Approval for an alternate contract sterilizer at Griffith Micro Science, New York facility, 84 Park Road, Queensbury, NY 12804. |
P910019/S005
2/23/98 |
TEC® Coronary Atherectomy System | InterVentional Technologies, Inc.
San Diego, CA 92123 |
Approval for a change to the 5.5F-7.5F TEC cutter catheters, involving the addition of a spiral groove on the inner surface of the cutter component. |
P910023/S030
2/2/98 |
Contour II/Angstrom II Implantable Cardioverter Defibrillator (ICD) Systems | St. Jude Medical, Inc.
Sunnyvale, CA 94086-6527 |
Approval for the Contour II/ Angstrom II Implantable Cardioverter/ Defibrillator (ICD) System, modifications to Programmer Software Version 5.1 to allow use with the Ventritex® Programmer Model PR-1500, use of the Contour II and Angstrom II pulse generator with the Medtronic® Transvene® Leads, changes in the Contour II/ Angstrom II Labeling and modifications to Programmer Software Version 5.1 to improve the ECG display and the accuracy of the reported data. |
P910023/S032
2/2/98 |
Cadence® Tiered Therapy Defibrillator System | St. Jude Medical, Inc.
Sunnyvale, CA 94086-6527 |
Approval for use of the Ventritex Contour Model V-145 and Contour LT Model V-135 pulse generators with the Medtronic® Transvene® Leads and changes in the Physician's Manuals. |
P920032/S004
2/27/98 |
MICRO-PACE Models 4553, 4570, and 3070a Dual-Chamber DDD Temporary Cardiac Pacemakers | PACE Medical, Inc.
Waltham, MA 02154 |
Approval for a modified switch guard design. |
P930012/S008
2/2/98 |
Champion HP PTCA Catheter with Wrap Sheathing System | United States Surgical Corporation
Norwalk, CT 06856 |
Approval for: 1) a line of Champion HP PTCA Catheters packaged with the Wrap Sheathing System; 2) the addition of quarter-sized balloons to this line of catheters extending the balloon diameter limits from 3.0-4.0mm to 2.5-4.5mm; and 3) a revised package insert which streamlines the Instructions for Use and compresses the previous package inserts for the 15mm and 20 mm long balloons into one combined insert. |
P930012/S009
2/23/98 |
Champion HP PTCA Catheters | United States Surgical Corporation
Norwalk, CT 06856 |
Approval for the addition of (1) quarter-size diameter balloons, including sizes of 2.5 mm, 2.75 mm, 3.25 mm, 3.75 mm, 4.25 mm, and 4.5 mm, and (2) a second radiopaque marker to all 20 mm long balloon catheters. The referenced devices are indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion. |
P930038/S007
2/2/98 |
Angio-Seal Hemostatic Puncture Closure Device | Quinton Instrument Company
Bothell, WA 98021-8906 |
Approval for modifications to the tamper tube component of the Angio-Seal Hemostatic Puncture Closure Device. |
*P950002/S005
2/6/98 |
BAK Interbody Fusion System | Spine-Tech, Inc.
Minneapolis, MN 55439-2029 |
Approval for an additional packaging configuration and gamma sterilization for the BAK and BAK/Proximity implants. |
*P950034/S005
2/25/98 |
Seprafilm Bioresorbable Membrane | Genzyme Corporation
Cambridge, MA 02139-1562 |
In this supplement the applicant agrees to submit an Investigational Device Exemptions (IDE) application for the modified postapproval safety study, is approved. We believe that this study, with the modifications as discussed, will satisfy the condition of approval for this PMA, but we may have additional comments on the IDE both as it related to the objectives of the postapproval study, depending on your responses, and your objective of collecting outcomes data on the incidence of small bowel obstruction. |
P960007/S005
2/12/98 |
Dermagraft-TC | Advanced Tissue Sciences, Inc.
La Jolla, CA 92037-1005 |
Approval for a change in manufacturing to automate the cell expansion process used to prepare the fibroblast cells for inoculation into the Dermagraft-TC growth system. |
P960040/S005
2/2/98 |
VENTAK® AV II AICD System | Guidant Corporation
St. Paul, MN 55112-5798 |
Approval for changes in the VENTAK® AV II Physician's Manual and Device Warranty. |
P960044/S001
2/11/98 |
Needle-Ease® 3500 Needle Destruction Device | Millenium Medical Supply, Inc.
Washington, DC 20004 |
Approval for a modified needle destruction device. The device, as modified, will be marketed under the trade name Needle-Ease® 3500 and is indicated for the disposal of standard plastic syringe-mounted hypodermic needles and aluminum hubbed dental needles in doctor's and dentist's offices. |
*P970008/S005
2/20/98 |
Urologix Targis System | Urologix
Minneapolis, MN 55447 |
Approval for changes to allow for the transport of the Targis Control Unit from site to site. |
P970035/S002
2/23/98 |
MicroStent® II Over-the-Wire Coronary Stent System GFX Over-the-Wire Coronary Stent System | Arterial Vascular Engineering, Inc.
Santa Rosa, CA 95403 |
Approval for a manufacturing site located at 3576 Unocal Place, Bldg. B, Santa Rosa, CA and 7975 Cameron Drive (extrusion)Windsor, CA. |
*Evaluated as a "Real-Time Review" PMA Supplement.
Summary of PMA Originals & Supplements Approved
Originals: 1
Supplements: 26
Summary of PMA Originals Under Review
Total Under Review: 75
Total Active: 30
Total On Hold: 44
Number Greater Than 180 Days: 7
Summary of PMA Supplements Under Review
Total Under Review: 217
Total Active: 137
Total On Hold: 79
Number Greater Than 180 Days: 8
Summary of All PMA Submissions Received
Originals: 1
Supplements: 39
Summary of PMA Supplement PMA Approval/Denial Decision Times
Number of Approvals: 26
Number of Denials: 0
Average Days Fr Receipt to Decision (Total Time): 178.9
Number Greater Than 180 Days: 5
Updated 3/19/1998
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