|
Device | Absorb GTi 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 | S009 |
Date Received | 05/17/2017 |
Decision Date | 06/23/2017 |
Withdrawal Date
|
05/11/2023 |
Product Code |
PNY |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement Extend the retest period from 60 months to 96 months for everolimus repackaged in Configuration I. |