|
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 | S063 |
Date Received | 07/09/2021 |
Decision Date | 08/05/2021 |
Product Code |
NIP |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Implement an alternative external process challenge device (ePCD) used in the sterilization process. |