PMA P170008S025
- Device
- EluNIR Ridaforolimus Eluting Coronary Stent System
- Applicant
- Medinol, Ltd.
- PMA number
- P170008
- Supplement
- S025
- Product code
- NIQ
- Decision date
- 2020-04-09
- Generic name
- Coronary drug-eluting stent
- Approval order statement
- Expand the use of automation for the hydrophilic coating line of the delivery catheter.
Current openFDA PMA Record#
- Device
- EluNIR Ridaforolimus Eluting Coronary Stent System
- Applicant
- Medinol, Ltd.
- PMA number
- P170008
- Supplement
- S025
- Product code
- NIQ
- Generic name
- Coronary drug-eluting stent
- Decision date
- 2020-04-09
- Decision code
- OK30
- Date received
- 2020-03-12
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Expand the use of automation for the hydrophilic coating line of the delivery catheter.