This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.
Approval for the absorb gt1 bioresorbable vascular scaffold (bvs) system. This device is indicated for improving coronary luminal diameter in patients with ischemic heart disease due to de novo native coronary artery lesions >=2. 5 mm to
| 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 | 2015-07-01 |
| Decision Date | 2016-07-05 |
| Notice Date | 2016-07-21 |
| PMA | P150023 |
| Supplement | S |
| Product Code | PNY |
| Docket Number | 16M-1914 |
| Advisory Committee | Cardiovascular |
| Expedited Review | No |
| Combination Product | Yes |
| Applicant Address | ABBOTT VASCULAR INC. 3200 Lakeside Drive santa Clara, CA 95054 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling Labeling Part 2 |
| Post-Approval Study: | Show Report Schedule and Study Progress |
| Approval Order: | Approval Order |
| 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 |