Resolute Onyx Zotarolimus-Eluting Coronary Stent System RX and OTW
FDA premarket approval P160043/S049 · decided 2021-12-14
Approval details
- PMA number
- P160043
- Supplement
- S049
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Resolute Onyx Zotarolimus-Eluting Coronary Stent System RX and OTW
- Generic name
- Coronary drug-eluting stent
- Applicant
- Medtronic Vascular
- Date received
- 2021-06-28
- Decision date
- 2021-12-14
- Days to decision
- 169 days
- Decision code
- APPR
- Product code
- NIQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Rosa, CA
- Statement
- Approval for changing the cleaning method for the extruder tooling used at the Santa Rosa site from a manual cleaning method to an automated cleaning method.
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