Resolute Onyx Zotarolimus-Eluting Coronary Stent System, Onyx Frontier Zotarolimus-Eluting Coronary Stent System
FDA premarket approval P160043/S076 · decided 2024-01-31
Approval details
- PMA number
- P160043
- Supplement
- S076
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Resolute Onyx Zotarolimus-Eluting Coronary Stent System, Onyx Frontier Zotarolimus-Eluting Coronary Stent System
- Applicant
- Medtronic Vascular
- Date received
- 2024-01-05
- Decision date
- 2024-01-31
- Days to decision
- 26 days
- Decision code
- OK30
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Rosa, CA
- Statement
- relocation of the repackaging process from the current building to a new building within the same campus
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