PMA P170008S010
- Device
- EluNIR™ Ridaforolimus Eluting Coronary Stent System
- Applicant
- Medinol, Ltd.
- PMA number
- P170008
- Supplement
- S010
- Product code
- NIQ
- Decision date
- 2018-11-16
- Classification
- Coronary Drug-eluting Stent
- Generic name
- Coronary drug-eluting stent
- Approval order statement
- Addition of a semi-automatic flare machine for manufacturing the delivery system.
Current openFDA PMA Record#
- Device
- EluNIR™ Ridaforolimus Eluting Coronary Stent System
- Applicant
- Medinol, Ltd.
- PMA number
- P170008
- Supplement
- S010
- Product code
- NIQ
- Generic name
- Coronary drug-eluting stent
- Decision date
- 2018-11-16
- Decision code
- OK30
- Date received
- 2018-10-19
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Addition of a semi-automatic flare machine for manufacturing the delivery system.