|
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 | S003 |
Date Received | 08/05/2016 |
Decision Date | 10/10/2017 |
Withdrawal Date
|
05/11/2023 |
Product Code |
PNY |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Postapproval Study Protocol - OSB |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement Approval for your premarket approval application (PMA) request that we place your study on hold. |