PMA P170008S021
- Device
- EluNIR™ Ridaforolimus Eluting Coronary Stent System
- Applicant
- Medinol, Ltd.
- PMA number
- P170008
- Supplement
- S021
- Product code
- NIQ
- Decision date
- 2019-09-20
- Classification
- Coronary Drug-eluting Stent
- Generic name
- Coronary drug-eluting stent
- Approval order statement
- Change to the stent crimping manufacturing process for the 3.50 x 8 mm EluNIR stent.
Current openFDA PMA Record#
- Device
- EluNIR™ Ridaforolimus Eluting Coronary Stent System
- Applicant
- Medinol, Ltd.
- PMA number
- P170008
- Supplement
- S021
- Product code
- NIQ
- Generic name
- Coronary drug-eluting stent
- Decision date
- 2019-09-20
- Decision code
- OK30
- Date received
- 2019-08-22
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change to the stent crimping manufacturing process for the 3.50 x 8 mm EluNIR stent.