PMA P160043S090
- Device
- Onyx Frontier Zotarolimus Eluting Coronary Stent System
- Applicant
- Medtronic Vascular
- PMA number
- P160043
- Supplement
- S090
- Product code
- NIQ
- Decision date
- 2026-03-25
- Classification
- Cardiovascular
- Generic name
- Coronary drug-eluting stent
Current openFDA PMA Record#
- Device
- Onyx Frontier Zotarolimus Eluting Coronary Stent System
- Applicant
- Medtronic Vascular
- PMA number
- P160043
- Supplement
- S090
- Product code
- NIQ
- Generic name
- Coronary drug-eluting stent
- Decision date
- 2026-03-25
- Decision code
- OK30
- Date received
- 2026-02-23
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier