Resolute Onyx Zotarolimus Eluting Coronary Stent System
FDA premarket approval P160043/S013 · decided 2019-01-17
Approval details
- PMA number
- P160043
- Supplement
- S013
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Resolute Onyx Zotarolimus Eluting Coronary Stent System
- Generic name
- Coronary drug-eluting stent
- Applicant
- Medtronic Vascular
- Date received
- 2018-02-13
- Decision date
- 2019-01-17
- Days to decision
- 338 days
- Decision code
- APPR
- Product code
- NIQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Rosa, CA
- Statement
- Approval to introduce changes to the drug-polymer coating process.
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