Resolute Onyx Zotarolimus-Eluting Coronary Stent System
FDA premarket approval P160043/S060 · decided 2022-09-29
Approval details
- PMA number
- P160043
- Supplement
- S060
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Trade name
- Resolute Onyx Zotarolimus-Eluting Coronary Stent System
- Generic name
- Coronary drug-eluting stent
- Applicant
- Medtronic Vascular
- Date received
- 2022-04-07
- Decision date
- 2022-09-29
- Days to decision
- 175 days
- Decision code
- APPR
- Product code
- NIQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Rosa, CA
- Statement
- Approval for updated labeling for the the Resolute Onyx Zotarolimus-Eluting Coronary Stent System electronic Instructions for Use (eIFU) to reflect the long-term data from The RESOLUTE ONYX CTO Post-Approval Study.
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