PMA P170008
- Device
- EluNIR™ Ridaforolimus Eluting Coronary Stent System
- Applicant
- Medinol, Ltd.
- PMA number
- P170008
- Supplement
- S039
- Product code
- NIQ
- Decision date
- 2026-03-26
- Generic name
- Coronary drug-eluting stent
- Approval order statement
- a shelf-life extension of absorbers used in the packaging of the stent systems
Current openFDA PMA Record#
- Device
- EluNIR™ Ridaforolimus Eluting Coronary Stent System
- Applicant
- Medinol, Ltd.
- PMA number
- P170008
- Supplement
- S062
- Product code
- NIQ
- Generic name
- Coronary drug-eluting stent
- Decision date
- 2026-03-26
- Decision code
- OK30
- Date received
- 2026-02-24
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- a shelf-life extension of absorbers used in the packaging of the stent systems