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.
| Device | SLENDER Sirolimus-Eluting Coronary Stent Integrated Delivery System(SLENDER IDS®), DIRECT Sirolimus-Eluting Coronary Ste |
| Generic Name | Coronary Drug-eluting Stent |
| Applicant | Svelte Medical Systems, Inc.675 Central Avenue, Suite 2new Providence, NJ 07974 PMA NumberP210014 Supplement NumberS001 Date Received01/12/2022 Decision Date04/08/2022 Product Code NIQ Advisory Committee Cardiovascular Supplement Typenormal 180 Day Track No User Fee Supplement Reason Postapproval Study Protocol Expedited Review Granted? No |
| Date Received | 2022-01-12 |
| Decision Date | 2022-04-08 |
| PMA | P210014 |
| Supplement | S001 |
| Product Code | NIQ |
| Advisory Committee | Cardiovascular |
| Supplement Type | Normal 180 Day Track No User Fee |
| Supplement Reason | Postapproval Study Protocol |
| Expedited Review | No |
| Combination Product | Yes |
| Applicant Address | Svelte Medical Systems, Inc. 675 Central Avenue, Suite 2 new Providence, NJ 07974 PMA NumberP210014 Supplement NumberS001 Date Received01/12/2022 Decision Date04/08/2022 Product Code NIQ Advisory Committee Cardiovascular Supplement Typenormal 180 Day Track No User Fee Supplement Reason Postapproval Study Protocol Expedited Review Granted? No Combination ProductYes Approval Order Statement Approval Of The Protocol For The Post-approval Study (PAS) Referenced Above. The PAS Protocol Has Been Submitted To Comply With The Conditions Of Approval Outlined In Our Approval Order For P210014. |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P210014 | Original Filing | |
| S001 | 2022-01-12 | Normal 180 Day Track No User Fee |