- Device
- Resolute Onyx Rapid Exchange Zotarolimus-Eluting Coronary Stent System, Resoulute Onyx Over The Wire Zotarolimus-Eluting
- Applicant
- Medtronic Vascular
- PMA number
- P160043
- Supplement
- S063
- Product code
- NIQ
- Generic name
- Coronary drug-eluting stent
- Decision date
- 2022-11-28
- Decision code
- OK30
- Date received
- 2022-11-18
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Internal facility transfer of component extrusion and secondary cutting manufacturing operations.