PMA P170008S037
- Device
- EluNIR™ Ridaforolimus Eluting Coronary Stent System
- Applicant
- Medinol, Ltd.
- Product code
- NIQ
- Decision date
- 2023-10-20
- Generic name
- Coronary drug-eluting stent
- Approval order statement
- Approval for the addition of radiopaque (RO) markers to the stent edges and RO coating to the internal distal tip material.
Current openFDA PMA Record#
- Device
- EluNIR™ Ridaforolimus Eluting Coronary Stent System
- Applicant
- Medinol, Ltd.
- PMA number
- P170008
- Supplement
- S037
- Product code
- NIQ
- Generic name
- Coronary drug-eluting stent
- Decision date
- 2023-10-20
- Decision code
- APPR
- Date received
- 2021-09-15
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for the addition of radiopaque (RO) markers to the stent edges and RO coating to the internal distal tip material.