|
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 | S001 |
Date Received | 07/11/2016 |
Decision Date | 10/07/2016 |
Withdrawal Date
|
05/11/2023 |
Product Code |
PNY |
Advisory Committee |
Cardiovascular |
Clinical Trials | NCT00856856
|
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement Approval for a shelf life extension from 12 months to 18 months for the small scaffold design (2.5 and 3.0mm diameters), and the implementation of an alternate temperature monitoring system. |