|
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 | S006 |
Date Received | 10/24/2016 |
Decision Date | 11/22/2016 |
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 Add an alternate supplier of platinum marker beads and to automate the marker bead placement process. |