Resolute Onyx Zotarolimus-Eluting Coronary Stent Systems, Onyx Frontier Zotarolimus-Eluting Coronary Stent Systems
FDA premarket approval P160043/S065 · decided 2023-03-23
Approval details
- PMA number
- P160043
- Supplement
- S065
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Resolute Onyx Zotarolimus-Eluting Coronary Stent Systems, Onyx Frontier Zotarolimus-Eluting Coronary Stent Systems
- Generic name
- Coronary drug-eluting stent
- Applicant
- Medtronic Vascular
- Date received
- 2023-02-21
- Decision date
- 2023-03-23
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- NIQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Rosa, CA
- Statement
- Remove the requirement to complete non-stability indicating tests as part of the annual stability studies for the Resolute Onyx and Onyx Frontier Zotarolimus-Eluting Coronary Stent Systems.
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