The slender sirolimus-eluting coronary stent integrated delivery system is indicated for improving coronary artery luminal diameter in patients with symptomatic heart disease due to atherosclerotic lesions = 2. 25 mm to
| Device | SLENDER Sirolimus-Eluting Coronary Stent Integrated Delivery System and DIRECT Sirolimus-Eluting Coronary Stent Rapid Ex |
| Generic Name | Coronary Drug-eluting Stent |
| Applicant | Svelte Medical Systems, Inc. |
| Date Received | 2021-04-01 |
| Decision Date | 2021-12-13 |
| PMA | P210014 |
| Supplement | S |
| Product Code | NIQ |
| Advisory Committee | Cardiovascular |
| Expedited Review | No |
| Combination Product | Yes |
| Applicant Address | Svelte Medical Systems, Inc. 675 Central Avenue, Suite 2 new Providence, NJ 07974 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Approval Order: | Approval Order |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P210014 | Original Filing | |
| S001 | 2022-01-12 | Normal 180 Day Track No User Fee |