PMA P160043S046
- Device
- Resolute Onyx Zotarolimus-Eluting Coronary Stent System (hereafter called Resolute Onyx)
- Applicant
- Medtronic Vascular
- PMA number
- P160043
- Supplement
- S046
- Product code
- NIQ
- Decision date
- 2021-05-11
- Generic name
- Coronary drug-eluting stent
- Approval order statement
- Transfer of component extrusion manufacturing operations from the Santa Rosa to the Danvers site.
Current openFDA PMA Record#
- Device
- Resolute Onyx Zotarolimus-Eluting Coronary Stent System (hereafter called Resolute Onyx)
- Applicant
- Medtronic Vascular
- PMA number
- P160043
- Supplement
- S046
- Product code
- NIQ
- Generic name
- Coronary drug-eluting stent
- Decision date
- 2021-05-11
- Decision code
- OK30
- Date received
- 2021-04-12
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Transfer of component extrusion manufacturing operations from the Santa Rosa to the Danvers site.