PMA P160043S094
- Device
- Resolute Onyx Zotarolimus-Eluting Coronary Stent System; Onyx Frontier Zotarolimus-Eluting Coronary Stent System Stent S
- Applicant
- Medtronic Vascular
- PMA number
- P160043
- Supplement
- S094
- Product code
- NIQ
- Decision date
- 2026-06-05
- Classification
- Cardiovascular
- Generic name
- Coronary drug-eluting stent
- Approval order statement
- changes to the mandrel cleaning process
Current openFDA PMA Record#
- Device
- Resolute Onyx Zotarolimus-Eluting Coronary Stent System; Onyx Frontier Zotarolimus-Eluting Coronary Stent System Stent S
- Applicant
- Medtronic Vascular
- PMA number
- P160043
- Supplement
- S094
- Product code
- NIQ
- Generic name
- Coronary drug-eluting stent
- Decision date
- 2026-06-05
- Decision code
- OK30
- Date received
- 2026-05-07
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- changes to the mandrel cleaning process