|
Device | Innova Vascular Self-Expanding Stent with Delivery System |
Generic Name | STENT, SUPERFICIAL FEMORAL ARTERY |
Applicant | BOSTON SCIENTIFIC CORPORATION ONE SCIMED PLACE MAPLE GROVE, MN 55311-1566 |
PMA Number | P140028 |
Supplement Number | S057 |
Date Received | 03/16/2020 |
Decision Date | 04/13/2020 |
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 Update to the sterilization cycle at the BSC Coventry, Rhode Island facility and the Steris Tullamore, Ireland contract sterilization facility. |