|
Device | Absorb GT1 Bioresorbable Vascular Scaffold (BVS) System |
Generic Name | Absorbable coronary drug-eluting stent |
Applicant | ABBOTT VASCULAR INC. 3200 Lakeside Drive Santa Clara, CA 95054 |
PMA Number | P150023 |
Supplement Number | S010 |
Date Received | 03/01/2018 |
Decision Date | 05/30/2018 |
Withdrawal Date
|
05/11/2023 |
Product Code |
PNY |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement Approval for implementation of everolimus BHT manufactured at a new manufacturing site. |