Resolute Onyx OTW Zotarolimus-Eluting Coronary Stent Systems
FDA premarket approval P160043/S057 · decided 2022-01-13
Approval details
- PMA number
- P160043
- Supplement
- S057
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Resolute Onyx OTW Zotarolimus-Eluting Coronary Stent Systems
- Generic name
- Coronary drug-eluting stent
- Applicant
- Medtronic Vascular
- Date received
- 2021-12-16
- Decision date
- 2022-01-13
- Days to decision
- 28 days
- Decision code
- APPR
- Product code
- NIQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Rosa, CA
- Statement
- Approval for additional visual verification at the attach bifurcate luer workstep.
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