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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
POB 58165
Tel Aviv 61581
PMA NumberP170008
Supplement NumberS010
Date Received10/19/2018
Decision Date11/16/2018
Product Code NIQ 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement  
Addition of a semi-automatic flare machine for manufacturing the delivery system.
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