PMA P040037S103

Device: GORE VIABAHN Endoprosthesis
Applicant: W. L. Gore & Associates, Inc.
PMA number: P040037
Supplement: S103
Product code: NIP
Decision date: 2017-09-27
Classification: Stent, Superficial Femoral Artery
Generic name: STENT, SUPERFICIAL FEMORAL ARTERY
Approval order statement: Additional supplier of films used in the manufacturing of the GORE EXCLUDER AAA Endoprosthesis, GORE VIATORR TIPS Endoprosthesis, GORE TAG Thoracic Endoprosthesis, GORE CARDIOFORM Septal Occluder, and GORE VIABHAN Endoprosthesis with and without Heparin Bioactive Surface.

Current openFDA PMA Record#

Device: GORE VIABAHN Endoprosthesis
Applicant: W. L. Gore & Associates, Inc.
PMA number: P040037
Supplement: S103
Product code: NIP
Generic name: STENT, SUPERFICIAL FEMORAL ARTERY
Decision date: 2017-09-27
Decision code: OK30
Date received: 2017-08-29
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Additional supplier of films used in the manufacturing of the GORE EXCLUDER AAA Endoprosthesis, GORE VIATORR TIPS Endoprosthesis, GORE TAG Thoracic Endoprosthesis, GORE CARDIOFORM Septal Occluder, and GORE VIABHAN Endoprosthesis with and without Heparin Bioactive Surface.