PMA P170008S002
- Device
- EluNIR™ Ridaforolimus Eluting Coronary Stent System
- Applicant
- Medinol, Ltd.
- PMA number
- P170008
- Supplement
- S002
- Product code
- NIQ
- Decision date
- 2018-04-17
- Classification
- Coronary Drug-eluting Stent
- Generic name
- Coronary drug-eluting stent
- Approval order statement
- Approval for the addition of two new balloon manufacturing machines.
Current openFDA PMA Record#
- Device
- EluNIR™ Ridaforolimus Eluting Coronary Stent System
- Applicant
- Medinol, Ltd.
- PMA number
- P170008
- Supplement
- S002
- Product code
- NIQ
- Generic name
- Coronary drug-eluting stent
- Decision date
- 2018-04-17
- Decision code
- APPR
- Date received
- 2018-02-21
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for the addition of two new balloon manufacturing machines.