|
Device | LifeStent Vascular Stent Systems |
Generic Name | STENT, SUPERFICIAL FEMORAL ARTERY |
Applicant | BARD PERIPHERAL VASCULAR, INC. 1415 WEST 3RD ST. TEMPE, AZ 85281 |
PMA Number | P070014 |
Supplement Number | S060 |
Date Received | 05/21/2020 |
Decision Date | 05/19/2021 |
Product Code |
NIP |
Advisory Committee |
Cardiovascular |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval an alternate supplier for the primary and secondary sheath components of the LifeStent Vascular Stent Systems. |