Svelte SLENDER® Sirolimus-Eluting Coronary Stent Integrated Delivery System (SLENDER IDS®), Svelte DIRECT Sirolimus-Elut
FDA premarket approval P210014/S002 · decided 2023-04-06
Approval details
- PMA number
- P210014
- Supplement
- S002
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Trade name
- Svelte SLENDER® Sirolimus-Eluting Coronary Stent Integrated Delivery System (SLENDER IDS®), Svelte DIRECT Sirolimus-Elut
- Generic name
- Coronary drug-eluting stent
- Applicant
- Advanced Bifurcation Systems, Inc.
- Date received
- 2023-03-14
- Decision date
- 2023-04-06
- Days to decision
- 23 days
- Decision code
- APPR
- Product code
- NIQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Livermore, CA
- Statement
- Approval to terminate of both PAS clinical studies, PAS001 continued follow-up of OPTIMIZE Clinical Study and PAS002 DIRECT IV Study
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.