PMA P160043S057
- Device
- Resolute Onyx OTW Zotarolimus-Eluting Coronary Stent Systems
- Applicant
- Medtronic Vascular
- PMA number
- P160043
- Supplement
- S057
- Product code
- NIQ
- Decision date
- 2022-01-13
- Generic name
- Coronary drug-eluting stent
- Approval order statement
- Approval for additional visual verification at the attach bifurcate luer workstep.
Current openFDA PMA Record#
- Device
- Resolute Onyx OTW Zotarolimus-Eluting Coronary Stent Systems
- Applicant
- Medtronic Vascular
- PMA number
- P160043
- Supplement
- S057
- Product code
- NIQ
- Generic name
- Coronary drug-eluting stent
- Decision date
- 2022-01-13
- Decision code
- APPR
- Date received
- 2021-12-16
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for additional visual verification at the attach bifurcate luer workstep.