PMA P170008S035
- Device
- EluNIR™ Ridaforolimus Eluting Coronary Stent System
- Applicant
- Medinol, Ltd.
- PMA number
- P170008
- Supplement
- S035
- Product code
- NIQ
- Decision date
- 2021-04-16
- Generic name
- Coronary drug-eluting stent
- Approval order statement
- Introduction of an automated ablation method for the hypotube components.
Current openFDA PMA Record#
- Device
- EluNIR™ Ridaforolimus Eluting Coronary Stent System
- Applicant
- Medinol, Ltd.
- PMA number
- P170008
- Supplement
- S035
- Product code
- NIQ
- Generic name
- Coronary drug-eluting stent
- Decision date
- 2021-04-16
- Decision code
- OK30
- Date received
- 2021-03-18
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Introduction of an automated ablation method for the hypotube components.