|
Device | GORE® VIABAHN® Endoprosthesis, GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface |
Generic Name | STENT, SUPERFICIAL FEMORAL ARTERY |
Applicant | W.L. GORE & ASSOCIATES,INC 3450 WEST KILTIE LN. P.O. BOX 500 FLAGSTAFF, AZ 86002-0500 |
PMA Number | P040037 |
Supplement Number | S163 |
Date Received | 11/15/2023 |
Decision Date | 01/03/2024 |
Product Code |
NIP |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for labeling updates to the Gore Viabahn Endoprosthesis and the Gore Viabahn Endoprosthesis with Heparin Bioactive Surface |