|
Device | LifeStent Vascular Stent System |
Generic Name | STENT, SUPERFICIAL FEMORAL ARTERY |
Applicant | BARD PERIPHERAL VASCULAR, INC. 1415 WEST 3RD ST. TEMPE, AZ 85281 |
PMA Number | P070014 |
Supplement Number | S065 |
Date Received | 02/21/2023 |
Decision Date | 07/27/2023 |
Product Code |
NIP |
Advisory Committee |
Cardiovascular |
Clinical Trials | NCT00712309
|
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 to update the labeling to include clinical results from the LifeStent Vascular Stent Systems post-approval study (Popliteal Indication) |