|
Device | Svelte SLENDER® Sirolimus-Eluting Coronary Stent Integrated Delivery System (SLENDER IDS®), Svelte DIRECT Sirolimus-Elut |
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 | S002 |
Date Received | 03/14/2023 |
Decision Date | 04/06/2023 |
Withdrawal Date
|
03/14/2023 |
Product Code |
NIQ |
Advisory Committee |
Cardiovascular |
Clinical Trials | NCT01788150
|
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 to terminate of both PAS clinical studies, PAS001 continued follow-up of OPTIMIZE Clinical Study and PAS002 DIRECT IV Study |