PMA P170008S032
- Device
- EluNIR™ Ridaforolimus Eluting Coronary Stent System
- Applicant
- Medinol, Ltd.
- Product code
- NIQ
- Decision date
- 2021-08-20
- Generic name
- Coronary drug-eluting stent
- Approval order statement
- Approval for updates to the device labeling reflecting the 5-year continued follow-up of the BIONICS Clinical Study.
Current openFDA PMA Record#
- Device
- EluNIR™ Ridaforolimus Eluting Coronary Stent System
- Applicant
- Medinol, Ltd.
- PMA number
- P170008
- Supplement
- S032
- Product code
- NIQ
- Generic name
- Coronary drug-eluting stent
- Decision date
- 2021-08-20
- Decision code
- APPR
- Date received
- 2021-02-22
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Approval order statement
- Approval for updates to the device labeling reflecting the 5-year continued follow-up of the BIONICS Clinical Study.