PMA P040037S110

Device: GORE VIABAHN Endoprosthesis
Applicant: W. L. Gore & Associates, Inc.
PMA number: P040037
Supplement: S110
Product code: NIP
Decision date: 2018-03-06
Classification: Stent, Superficial Femoral Artery
Generic name: STENT, SUPERFICIAL FEMORAL ARTERY
Approval order statement: Implement changes to the VIABAHN Stent Graft Stripping Machine used in the manufacture of the GORE VIABAHN Endoprosthesis and GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface.

Current openFDA PMA Record#

Device: GORE VIABAHN Endoprosthesis
Applicant: W. L. Gore & Associates, Inc.
PMA number: P040037
Supplement: S110
Product code: NIP
Generic name: STENT, SUPERFICIAL FEMORAL ARTERY
Decision date: 2018-03-06
Decision code: OK30
Date received: 2018-02-06
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Implement changes to the VIABAHN Stent Graft Stripping Machine used in the manufacture of the GORE VIABAHN Endoprosthesis and GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface.