|
Device | LifeStream Balloon Expandable Vascular Covered Stent |
Generic Name | Iliac covered stent, arterial |
Applicant | BARD PERIPHERAL VASCULAR, INC. 1625 WEST 3RD ST. TEMPE, AZ 85281-1740 |
PMA Number | P160024 |
Supplement Number | S007 |
Date Received | 06/27/2019 |
Decision Date | 09/09/2019 |
Product Code |
PRL |
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 updates to the LifeStream Balloon Expandable Vascular Covered Stent labeling to incorporate the 3-year results of the BOLSTER Clinical Study. |