PMA P160043S054
- Device
- Resolute Onyx Zotarolimus-Eluting Coronary Stent System, Resolute Onyx Zotarolimus-Eluting Coronary Stent System (2.0mm)
- Applicant
- Medtronic Vascular
- PMA number
- P160043
- Supplement
- S054
- Product code
- NIQ
- Decision date
- 2021-08-31
- Generic name
- Coronary drug-eluting stent
- Approval order statement
- Change to the analytical chemistry method for lot release.
Current openFDA PMA Record#
- Device
- Resolute Onyx Zotarolimus-Eluting Coronary Stent System, Resolute Onyx Zotarolimus-Eluting Coronary Stent System (2.0mm)
- Applicant
- Medtronic Vascular
- PMA number
- P160043
- Supplement
- S054
- Product code
- NIQ
- Generic name
- Coronary drug-eluting stent
- Decision date
- 2021-08-31
- Decision code
- OK30
- Date received
- 2021-08-02
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change to the analytical chemistry method for lot release.