SLENDER Sirolimus-Eluting Coronary Stent Integrated Delivery System(SLENDER IDS®), DIRECT Sirolimus-Eluting Coronary Ste
FDA premarket approval P210014/S001 · decided 2022-04-08
Approval details
- PMA number
- P210014
- Supplement
- S001
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Trade name
- SLENDER Sirolimus-Eluting Coronary Stent Integrated Delivery System(SLENDER IDS®), DIRECT Sirolimus-Eluting Coronary Ste
- Generic name
- Coronary drug-eluting stent
- Applicant
- Advanced Bifurcation Systems, Inc.
- Date received
- 2022-01-12
- Decision date
- 2022-04-08
- Days to decision
- 86 days
- Decision code
- APPR
- Product code
- NIQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Livermore, CA
- Statement
- Approval of the protocol for the post-approval study (PAS) protocol.
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