Resolute Onyx Zotarolimus-Eluting Coronary Stent Systems
FDA premarket approval P160043/S051 · decided 2021-08-13
Approval details
- PMA number
- P160043
- Supplement
- S051
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Resolute Onyx Zotarolimus-Eluting Coronary Stent Systems
- Generic name
- Coronary drug-eluting stent
- Applicant
- Medtronic Vascular
- Date received
- 2021-07-15
- Decision date
- 2021-08-13
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- NIQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Rosa, CA
- Statement
- Allow for shelf life expiration date (SLED) and pouch and labeling rework at Medtronic Memphis Distribution Center.
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