PMA P170008S038
- Device
- EluNIR™ Ridaforolimus Eluting Coronary Stent System
- Applicant
- Medinol, Ltd.
- PMA number
- P170008
- Supplement
- S038
- Product code
- NIQ
- Decision date
- 2022-02-10
- Generic name
- Coronary drug-eluting stent
- Approval order statement
- Approval for the addition of the 2.25mm diameter EluNIR stent system to the approved EluNIR matrix
Current openFDA PMA Record#
- Device
- EluNIR™ Ridaforolimus Eluting Coronary Stent System
- Applicant
- Medinol, Ltd.
- PMA number
- P170008
- Supplement
- S038
- Product code
- NIQ
- Generic name
- Coronary drug-eluting stent
- Decision date
- 2022-02-10
- Decision code
- APPR
- Date received
- 2021-11-12
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for the addition of the 2.25mm diameter EluNIR stent system to the approved EluNIR matrix