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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 NumberS045
Date Received06/27/2023
Decision Date07/20/2023
Product Code NIQ 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Replacement of the color component of the transition outer which is part of EluNIR's delivery system transition shaft.
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