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PMA Final Decisions Rendered for February 1998

 related information

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 for February 1998. This list is generated on a monthly basis.

PMA Original Approvals

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

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