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 your premarket approval application (pma) request that we place your study on hold.
| 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 | 2016-08-05 |
| Decision Date | 2017-10-10 |
| PMA | P150023 |
| Supplement | S003 |
| Product Code | PNY |
| Advisory Committee | Cardiovascular |
| Supplement Type | Normal 180 Day Track No User Fee |
| Supplement Reason | Postapproval Study Protocol - Osb |
| 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 |