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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 NumberS029
Date Received10/26/2020
Decision Date11/24/2020
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  
Changes to the analytical test methods of the ridaforolimus drug substance.
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