|
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 2 New Providence, NJ 07974 |
PMA Number | P210014 |
Supplement Number | S001 |
Date Received | 01/12/2022 |
Decision Date | 04/08/2022 |
Withdrawal Date
|
03/14/2023 |
Product Code |
NIQ |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Postapproval Study Protocol |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement Approval of the protocol for the post-approval study (PAS) protocol. |