PMA P170008S028
- Device
- EluNIR Ridaforolimus Eluting Coronary Stent System
- Applicant
- Medinol, Ltd.
- PMA number
- P170008
- Supplement
- S028
- Product code
- NIQ
- Decision date
- 2020-08-20
- Generic name
- Coronary drug-eluting stent
- Approval order statement
- Changes to the sampling plan for the mechanical and packaging release testing.
Current openFDA PMA Record#
- Device
- EluNIR Ridaforolimus Eluting Coronary Stent System
- Applicant
- Medinol, Ltd.
- PMA number
- P170008
- Supplement
- S028
- Product code
- NIQ
- Generic name
- Coronary drug-eluting stent
- Decision date
- 2020-08-20
- Decision code
- OK30
- Date received
- 2020-07-23
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Changes to the sampling plan for the mechanical and packaging release testing.