PMA P160043S043
- Device
- Resolute Onyx Zotarolimus-Eluting Coronary Stent System
- Applicant
- Medtronic Vascular
- PMA number
- P160043
- Supplement
- S043
- Product code
- NIQ
- Decision date
- 2021-02-23
- Generic name
- Coronary drug-eluting stent
- Approval order statement
- Alternate supplier for the protective sheath component.
Current openFDA PMA Record#
- Device
- Resolute Onyx Zotarolimus-Eluting Coronary Stent System
- Applicant
- Medtronic Vascular
- PMA number
- P160043
- Supplement
- S043
- Product code
- NIQ
- Generic name
- Coronary drug-eluting stent
- Decision date
- 2021-02-23
- Decision code
- OK30
- Date received
- 2021-01-25
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Alternate supplier for the protective sheath component.