PMA P040037S093

Device: GORE VIABAHN ENDOPROSTHESIS
Applicant: W. L. Gore & Associates, Inc.
PMA number: P040037
Supplement: S093
Product code: NIP
Decision date: 2016-09-21
Classification: Stent, Superficial Femoral Artery
Generic name: STENT, SUPERFICIAL FEMORAL ARTERY
Approval order statement: Implementation of changes to zipper manufacturing which include the use of modified braider machines and a new oven rack and spatula to increase manufacturing capacity.

Current openFDA PMA Record#

Device: GORE VIABAHN ENDOPROSTHESIS
Applicant: W. L. Gore & Associates, Inc.
PMA number: P040037
Supplement: S093
Product code: NIP
Generic name: STENT, SUPERFICIAL FEMORAL ARTERY
Decision date: 2016-09-21
Decision code: OK30
Date received: 2016-08-25
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Implementation of changes to zipper manufacturing which include the use of modified braider machines and a new oven rack and spatula to increase manufacturing capacity.