|
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 | S037 |
Date Received | 09/15/2021 |
Decision Date | 10/20/2023 |
Product Code |
NIQ |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement Approval for the addition of radiopaque (RO) markers to the stent edges and RO coating to the internal distal tip material. |