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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 |
Date Received | 03/13/2017 |
Decision Date | 11/28/2017 |
Product Code |
NIQ |
Docket Number | 17M-6650 |
Notice Date | 12/15/2017 |
Advisory Committee |
Cardiovascular |
Clinical Trials | NCT01995487
|
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement Approval for the EluNIR Ridaforolimus Eluting Coronary Stent System. This device is indicated for improving coronary luminal diameter in patients with symptomatic heart disease due to de novo lesions <=30mm in length in native coronary arteries with reference diameter of 2.50mm to 4.25mm. |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling Labeling Part 2 |
Post-Approval Study | Show Report Schedule and Study Progress |
Supplements: |
S001 S002 S003 S004 S005 S006 S007 S008 S010 S011 S012 S013 S015 S016 S018 S019 S020 S021 S022 S024 S025 S028 S029 S030 S031 S032 S033 S034 S035 S036 S037 S038 S039 S040 S041 S042 S043 S044 S045 S046 S047 S048 |