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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 6158101
PMA NumberP170008
Supplement NumberS004
Date Received03/15/2018
Decision Date06/07/2018
Product Code NIQ 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for adding a manufacturing site for a component, the D-catheter delivery system, for the EluNIR Ridaforolimus Eluting Coronary Stent System.
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