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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
Classification Namecoronary drug-eluting stent
Generic Namecoronary drug-eluting stent
Applicant
Medinol, Ltd.
kiryat atidim, bldg. 8
pob 58165
tel aviv 61581
PMA NumberP170008
Date Received03/13/2017
Decision Date11/28/2017
Product Code
NIQ[ Registered Establishments with NIQ ]
Docket Number 17M-6650
Notice Date 12/15/2017
Advisory Committee Cardiovascular
Clinical Trials NCT01995487
NCT01995500
NCT02736344
NCT02834806
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 StudyShow Report Schedule and Study Progress
Supplements: S001 S002 S003 S004 S005 S006 S007 S008 S010 
S011 S012 S013 S015 S016 S018 S020 S021 
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