Resolute Onyx Zotarolimus Eluting Coronary Stent System RX and OTW; Onyx Frontier Zotarolimus Eluting Coronary Stent Sys
FDA premarket approval P160043/S087 · decided 2025-04-07
Approval details
- PMA number
- P160043
- Supplement
- S087
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Resolute Onyx Zotarolimus Eluting Coronary Stent System RX and OTW; Onyx Frontier Zotarolimus Eluting Coronary Stent Sys
- Generic name
- Coronary drug-eluting stent
- Applicant
- Medtronic Vascular
- Date received
- 2025-03-10
- Decision date
- 2025-04-07
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- NIQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Rosa, CA
- Statement
- the implementation of changes to the label printing system
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