Onyx Frontier Zotarolimus-Eluting Coronary Stent Systems
FDA premarket approval P160043/S066 · decided 2023-08-08
Approval details
- PMA number
- P160043
- Supplement
- S066
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Onyx Frontier Zotarolimus-Eluting Coronary Stent Systems
- Generic name
- Coronary drug-eluting stent
- Applicant
- Medtronic Vascular
- Date received
- 2023-03-20
- Decision date
- 2023-08-08
- Days to decision
- 141 days
- Decision code
- APPR
- Product code
- NIQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Rosa, CA
- Statement
- Approval for the transfer of component extrusion manufacturing operations for the Onyx Frontier coextrusion balloons and the Onyx Frontier Bumped Inner components used in the manufacture of the Onyx Frontier device
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