|
Device | EluNIR™ Ridaforolimus Eluting Coronary Stent System |
Generic Name | Coronary drug-eluting stent |
Applicant | Medinol, Ltd. Kiryat Atidim, Bldg. 8 POB 58165 Tel Aviv 61581 |
PMA Number | P170008 |
Supplement Number | S032 |
Date Received | 02/22/2021 |
Decision Date | 08/20/2021 |
Product Code |
NIQ |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Labeling Change - PAS |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement Approval for updates to the device labeling reflecting the 5-year continued follow-up of the BIONICS Clinical Study. |