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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-CORONARY STENT ON RX SYSTEM
Generic NameSTENT, CORONARY
ApplicantMedinol, Ltd.
Kiryat Atidim, Bldg. 7
Entrance A, P.O.B. 58165
Tel-Aviv 61581
PMA NumberP110004
Supplement NumberS010
Date Received11/13/2014
Decision Date05/14/2015
Withdrawal Date11/02/2020
Product Code MAF 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Postapproval Study Protocol - OSB
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
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