Resolute Onyx Zotarolimus-Eluting Coronary Stent Systems
FDA premarket approval P160043/S052 · decided 2021-08-09
Approval details
- PMA number
- P160043
- Supplement
- S052
- 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
- 2021-07-16
- Decision date
- 2021-08-09
- Days to decision
- 24 days
- Decision code
- OK30
- Product code
- NIQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Rosa, CA
- Statement
- Introduction of new stent crimp equipment on the Resolute Onyx manufacturing line to perform the final crimp of the stent onto the balloon of the delivery system.
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