Resolute Onyx Zotarolimus Eluting Coronary Stent System Onyx Frontier Zotarolimus Eluting Coronary Stent System
FDA premarket approval P160043/S075 · decided 2024-06-21
Approval details
- PMA number
- P160043
- Supplement
- S075
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- 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
- 2023-12-13
- Decision date
- 2024-06-21
- Days to decision
- 191 days
- Decision code
- APPR
- Product code
- NIQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Rosa, CA
- Statement
- Approval for revisions to the labeling that incorporate the 36 month results of the RESOLUTE ONYX post approval clinical study.
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