- Device
- Resolute Onyx RX Zotarolimus-Eluting Coronary Stent System, Resolute Onyx OTW Zotarolimus-Eluting Coronary Stent System
- Applicant
- Medtronic Vascular
- PMA number
- P160043
- Supplement
- S056
- Product code
- NIQ
- Generic name
- Coronary drug-eluting stent
- Decision date
- 2021-11-24
- Decision code
- OK30
- Date received
- 2021-10-25
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Removal of a timepoint from the elution analytical lot release and stability testing.