PMA P170008S029
- Device
- EluNIR Ridaforolimus Eluting Coronary Stent System
- Applicant
- Medinol, Ltd.
- PMA number
- P170008
- Supplement
- S029
- Product code
- NIQ
- Decision date
- 2020-11-24
- Generic name
- Coronary drug-eluting stent
- Approval order statement
- Changes to the analytical test methods of the ridaforolimus drug substance.
Current openFDA PMA Record#
- Device
- EluNIR Ridaforolimus Eluting Coronary Stent System
- Applicant
- Medinol, Ltd.
- PMA number
- P170008
- Supplement
- S029
- Product code
- NIQ
- Generic name
- Coronary drug-eluting stent
- Decision date
- 2020-11-24
- Decision code
- OK30
- Date received
- 2020-10-26
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Changes to the analytical test methods of the ridaforolimus drug substance.