Resolute Onyx Rapid Exchange Zotarolimus- Eluting Coronary Stent System, Resolute Onyx Over The Wire Zotarolimus- Elutin
FDA premarket approval P160043/S078 · decided 2024-03-08
Approval details
- PMA number
- P160043
- Supplement
- S078
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Resolute Onyx Rapid Exchange Zotarolimus- Eluting Coronary Stent System, Resolute Onyx Over The Wire Zotarolimus- Elutin
- Generic name
- Coronary drug-eluting stent
- Applicant
- Medtronic Vascular
- Date received
- 2024-02-12
- Decision date
- 2024-03-08
- Days to decision
- 25 days
- Decision code
- OK30
- Product code
- NIQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Rosa, CA
- Statement
- use of additional sterilization chambers at the established sterilization site with a previously qualified and approved sterilization cycle
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