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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceEluNIR™ Ridaforolimus Eluting Coronary Stent System
Generic NameCoronary drug-eluting stent
ApplicantMedinol, Ltd.
Kiryat Atidim, Bldg. 8, P.O.B. 58165
Tel Aviv 6158101
PMA NumberP170008
Date Received03/13/2017
Decision Date11/28/2017
Product Code NIQ 
Docket Number 17M-6650
Notice Date 12/15/2017
Advisory Committee Cardiovascular
Clinical TrialsNCT01995487
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
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 OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
Post-Approval StudyShow 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 S049 S051 S052 S055 S056 
S057 S058 S059 S060 S061 S062 
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