Resolute Onyx Zotarolimus-Eluting Coronary Stent Systems
FDA premarket approval P160043/S007 · decided 2017-12-06
Approval details
- PMA number
- P160043
- Supplement
- S007
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Resolute Onyx Zotarolimus-Eluting Coronary Stent Systems
- Generic name
- Coronary drug-eluting stent
- Applicant
- Medtronic Vascular
- Date received
- 2017-09-25
- Decision date
- 2017-12-06
- Days to decision
- 72 days
- Decision code
- APPR
- Product code
- NIQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Rosa, CA
- Statement
- Approval for a material change to the distal inner shaft of the Resolute Onyx Zotarolimus-Eluting Coronary Stent Systems (RX & OTW).
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