PMA P160043S064
- Device
- Resolute Onyx Rapid Exchange Zotarolimus- Eluting Coronary Stent System, Resolute Onyx Over The Wire Zotarolimus- Elutin
- Applicant
- Medtronic Vascular
- PMA number
- P160043
- Supplement
- S064
- Product code
- NIQ
- Decision date
- 2022-12-01
- Generic name
- Coronary drug-eluting stent
- Approval order statement
- Implement an alternative bacterial water testing method.
Current openFDA PMA Record#
- Device
- Resolute Onyx Rapid Exchange Zotarolimus- Eluting Coronary Stent System, Resolute Onyx Over The Wire Zotarolimus- Elutin
- Applicant
- Medtronic Vascular
- PMA number
- P160043
- Supplement
- S064
- Product code
- NIQ
- Generic name
- Coronary drug-eluting stent
- Decision date
- 2022-12-01
- Decision code
- OK30
- Date received
- 2022-11-29
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Implement an alternative bacterial water testing method.