PMA P160043S096
- Device
- Resolute Onyx Zotarolimus-Eluting Coronary Stent Systems
- Applicant
- Medtronic Vascular
- PMA number
- P160043
- Supplement
- S096
- Product code
- NIQ
- Decision date
- 2026-10-16
- Classification
- Cardiovascular
- Generic name
- Coronary drug-eluting stent
- Approval order statement
- changing the point of finished device test sample collection
Current openFDA PMA Record#
- Device
- Resolute Onyx Zotarolimus-Eluting Coronary Stent Systems
- Applicant
- Medtronic Vascular
- PMA number
- P160043
- Supplement
- S096
- Product code
- NIQ
- Generic name
- Coronary drug-eluting stent
- Decision date
- 2026-10-16
- Decision code
- OK30
- Date received
- 2026-09-17
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- changing the point of finished device test sample collection