|
Device | Gore VIABAHN ENDOPROSTHESIS |
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 | S091 |
Date Received | 04/18/2016 |
Decision Date | 09/22/2016 |
Product Code |
NIP |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Labeling Change - PAS |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for a Post-Approval study labeling update to include the final study results for the extended follow-up 25cm Viabahn Endoprosthesis study. |