Resolute Onyx Coronary Stent System
FDA premarket approval P160043/S011 · decided 2018-03-15
Approval details
- PMA number
- P160043
- Supplement
- S011
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Resolute Onyx Coronary Stent System
- Generic name
- Coronary drug-eluting stent
- Applicant
- Medtronic Vascular
- Date received
- 2017-12-18
- Decision date
- 2018-03-15
- Days to decision
- 87 days
- Decision code
- APPR
- Product code
- NIQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Rosa, CA
- Statement
- Approval to introduce changes to the annual stability study design for the Resolute Onyx Coronary Stent System and Resolute Integrity Coronary Stent System.
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