PMA P170008S057
- Device
- EluNIR™ Ridaforolimus Eluting Coronary Stent System
- Applicant
- Medinol, Ltd.
- PMA number
- P170008
- Supplement
- S057
- Product code
- NIQ
- Decision date
- 2025-05-30
- Classification
- Cardiovascular
- Generic name
- Coronary drug-eluting stent
- Approval order statement
- changes to release testing requirements for balloon burst and leakage evaluation
Current openFDA PMA Record#
- Device
- EluNIR™ Ridaforolimus Eluting Coronary Stent System
- Applicant
- Medinol, Ltd.
- PMA number
- P170008
- Supplement
- S057
- Product code
- NIQ
- Generic name
- Coronary drug-eluting stent
- Decision date
- 2025-05-30
- Decision code
- OK30
- Date received
- 2025-04-30
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- changes to release testing requirements for balloon burst and leakage evaluation