PMA P040037S108

Device: GORE VIABAHN Endoprosthesis and GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface
Applicant: W. L. Gore & Associates, Inc.
PMA number: P040037
Supplement: S108
Product code: NIP
Decision date: 2017-12-28
Classification: Stent, Superficial Femoral Artery
Generic name: STENT, SUPERFICIAL FEMORAL ARTERY
Approval order statement: Implementation of an alternate resin, supplied by an alternate supplier, in the manufacture of radiopaque marker components of the GORE VIABAHN Endoprosthesis and GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface.

Current openFDA PMA Record#

Device: GORE VIABAHN Endoprosthesis and GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface
Applicant: W. L. Gore & Associates, Inc.
PMA number: P040037
Supplement: S108
Product code: NIP
Generic name: STENT, SUPERFICIAL FEMORAL ARTERY
Decision date: 2017-12-28
Decision code: OK30
Date received: 2017-12-05
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Implementation of an alternate resin, supplied by an alternate supplier, in the manufacture of radiopaque marker components of the GORE VIABAHN Endoprosthesis and GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface.