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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.
 
DeviceNIRXCELL COCR CORONARYSTENT ON RX SYSTEM
Generic NameSTENT, CORONARY
ApplicantMedinol, Ltd.
Kiryat Atidim, Bldg. 7
Entrance A, P.O.B. 58165
Tel-Aviv 61581
PMA NumberP110004
Supplement NumberS015
Date Received12/11/2015
Decision Date08/07/2017
Withdrawal Date11/02/2020
Product Code MAF 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Labeling Change - PAS
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for labeling updates to the Instructions for Use (IFU) to reflect the long-term data from the Post-Approval BLAST Placebo Cohort study.
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