Resolute Onyx Zotarolimus-Eluting Coronary Stent System
FDA premarket approval P160043/S021 · decided 2019-03-08
Approval details
- PMA number
- P160043
- Supplement
- S021
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Trade name
- Resolute Onyx Zotarolimus-Eluting Coronary Stent System
- Generic name
- Coronary drug-eluting stent
- Applicant
- Medtronic Vascular
- Date received
- 2019-01-09
- Decision date
- 2019-03-08
- Days to decision
- 58 days
- Decision code
- APPR
- Product code
- NIQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Rosa, CA
- Statement
- Approval of the protocol for the post-approval study (PAS) protocol.
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