|
Device | Innova Vascular Self-Expanding Stent System |
Generic Name | STENT, SUPERFICIAL FEMORAL ARTERY |
Applicant | BOSTON SCIENTIFIC CORPORATION ONE SCIMED PLACE MAPLE GROVE, MN 55311-1566 |
PMA Number | P140028 |
Supplement Number | S054 |
Date Received | 01/27/2020 |
Decision Date | 02/20/2020 |
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 Duplicate manufacturing line and equipment updates for a component of the device delivery system. |