|
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 | S152 |
Date Received | 02/14/2022 |
Decision Date | 05/26/2022 |
Product Code |
NIP |
Advisory Committee |
Cardiovascular |
Clinical Trials | NCT01108861
|
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Labeling Change - PAS |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement Approval for the labeling update to include the final results of the RELINE MAX New Enrollment Study (ISR 04-04) |