PMA P160043
- Device
- RESOLUTE ONYX ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM
- Applicant
- Medtronic Vascular
- PMA number
- P160043
- Supplement
- S064
- Product code
- NIQ
- Decision date
- 2026-05-29
- Generic name
- Coronary drug-eluting stent
- Approval order statement
- a change to in-process inspection of stent alignment balloons
Current openFDA PMA Record#
- Device
- RESOLUTE ONYX ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM
- Applicant
- Medtronic Vascular
- PMA number
- P160043
- Supplement
- S093
- Product code
- NIQ
- Generic name
- Coronary drug-eluting stent
- Decision date
- 2026-05-29
- Decision code
- OK30
- Date received
- 2026-05-01
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- a change to in-process inspection of stent alignment balloons