- Device
- Resolute Onyx Zotarolimus-Eluting Coronary Stent System, Onyx Frontier Zotarolimus-Eluting Coronary Stent System
- Applicant
- Medtronic Vascular
- PMA number
- P160043
- Supplement
- S061
- Product code
- NIQ
- Generic name
- Coronary drug-eluting stent
- Decision date
- 2022-06-15
- Decision code
- OK30
- Date received
- 2022-06-03
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Use of an electronic Manufacturing Execution System (MES) to replace the current paper-based device history record (DHR).