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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceEluNIR Ridaforolimus Eluting Coronary Stent System
Generic NameCoronary drug-eluting stent
ApplicantMedinol, Ltd.
Kiryat Atidim, Bldg. 8, P.O.B. 58165
Tel Aviv 61581
PMA NumberP170008
Supplement NumberS019
Date Received07/10/2019
Decision Date11/19/2019
Product Code NIQ 
Advisory Committee Cardiovascular
Clinical TrialsNCT03702608
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for the expansion of the EluNIR Ridaforolimus Eluting Coronary Stent System product matrix by adding stent length of 38 mm in diameters 2.75, 3.0, 3.5 and 4.0 mm. This device is indicated for improving coronary luminal diameter in patients with symptomatic heart disease due to de novo lesions <=36mm in length in native coronary arteries with reference diameter of 2.50mm to 4.25mm.
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