This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.
Approval for implementation of everolimus bht manufactured at a new manufacturing site.
| Device | Absorb GT1 Bioresorbable Vascular Scaffold (BVS) System |
| Classification Name | Absorbable Coronary Drug-eluting Stent |
| Generic Name | Absorbable Coronary Drug-eluting Stent |
| Applicant | ABBOTT VASCULAR INC. |
| Date Received | 2018-03-01 |
| Decision Date | 2018-05-30 |
| PMA | P150023 |
| Supplement | S010 |
| Product Code | PNY |
| Docket Number | Premarket Approval (PMA) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices Radia |
| Advisory Committee | Cardiovascular |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | Yes |
| Applicant Address | ABBOTT VASCULAR INC. 3200 Lakeside Drive santa Clara, CA 95054 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P150023 | Original Filing | |
| S010 | 2018-03-01 | Normal 180 Day Track |
| S009 | 2017-05-17 | 30-day Notice |
| S008 | 2017-04-14 | 30-day Notice |
| S007 | 2017-03-13 | 135 Review Track For 30-day Notice |
| S006 | 2016-10-24 | 30-day Notice |
| S005 | 2016-09-08 | 30-day Notice |
| S004 | ||
| S003 | 2016-08-05 | Normal 180 Day Track No User Fee |
| S002 | 2016-07-29 | Special (immediate Track) |
| S001 | 2016-07-11 | Normal 180 Day Track |