- Device
- Resolute Onyx Zotarolimus-Eluting Coronary Stent System, Onyx Frontier Zotarolimus-Eluting Coronary Stent System
- Applicant
- Medtronic Vascular
- PMA number
- P160043
- Supplement
- S055
- Product code
- NIQ
- Generic name
- Coronary drug-eluting stent
- Decision date
- 2022-05-12
- Decision code
- APPR
- Date received
- 2021-09-29
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for changes to the delivery system and marketing under the Onyx Frontier Zotarolimus-Eluting Coronary Stent System trade name.