Resolute Onyx Zotarolimus-Eluting Coronary Stent System, Onyx Frontier Zotarolimus-Eluting Coronary Stent System
FDA premarket approval P160043/S055 · decided 2022-05-12
Approval details
- PMA number
- P160043
- Supplement
- S055
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Resolute Onyx Zotarolimus-Eluting Coronary Stent System, Onyx Frontier Zotarolimus-Eluting Coronary Stent System
- Generic name
- Coronary drug-eluting stent
- Applicant
- Medtronic Vascular
- Date received
- 2021-09-29
- Decision date
- 2022-05-12
- Days to decision
- 225 days
- Decision code
- APPR
- Product code
- NIQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Rosa, CA
- Statement
- Approval for changes to the delivery system and marketing under the Onyx Frontier Zotarolimus-Eluting Coronary Stent System trade name.
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