Resolute Onyx Zotarolimus-Eluting Coronary Stent System
FDA premarket approval P160043/S027 · decided 2020-02-14
Approval details
- PMA number
- P160043
- Supplement
- S027
- 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
- 2019-08-21
- Decision date
- 2020-02-14
- Days to decision
- 177 days
- Decision code
- APPR
- Product code
- NIQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Rosa, CA
- Statement
- Approval for revisions to the labeling that incorporate the results of the RESOLUTE ONYX Core (2.25 mm - 4.0 mm) and REOSLUTE ONYX 2.00 mm Clinical Studies.
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