Resolute Onyx Coronary Stent System
FDA premarket approval P160043/S037 · decided 2020-10-05
Approval details
- PMA number
- P160043
- Supplement
- S037
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Resolute Onyx Coronary Stent System
- Generic name
- Coronary drug-eluting stent
- Applicant
- Medtronic Vascular
- Date received
- 2020-07-10
- Decision date
- 2020-10-05
- Days to decision
- 87 days
- Decision code
- APPR
- Product code
- NIQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Rosa, CA
- Statement
- Approval for a site change for packaging and labeling rework processes.
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