SLENDER Sirolimus-Eluting Coronary Stent Integrated Delivery System and DIRECT Sirolimus-Eluting Coronary Stent Rapid Ex
FDA premarket approval P210014 · decided 2021-12-13
Approval details
- PMA number
- P210014
- Trade name
- SLENDER Sirolimus-Eluting Coronary Stent Integrated Delivery System and DIRECT Sirolimus-Eluting Coronary Stent Rapid Ex
- Generic name
- Coronary drug-eluting stent
- Applicant
- Advanced Bifurcation Systems, Inc.
- Date received
- 2021-04-01
- Decision date
- 2021-12-13
- Days to decision
- 256 days
- Decision code
- APWD
- Product code
- NIQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Livermore, CA
- Statement
- Approval for the SLENDER Sirolimus-Eluting Coronary Stent Integrated Delivery System. The device is indicated for improving coronary artery luminal diameter in patients with symptomatic heart disease due to atherosclerotic lesions <= 24 mm in length in native coronary arteries with >= 2.25 mm to <= 4.00 mm reference vessel diameters, using direct stenting or pre-dilatation interventional techniques. DIRECT Sirolimus-Eluting Coronary Stent Rapid Exchange Delivery System is indicated for improving
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