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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
Generic NameSTENT, CORONARY
ApplicantMedinol, Ltd.
Kiryat Atidim, Bldg. 7
Entrance A, P.O.B. 58165
Tel-Aviv 61581
PMA NumberP110004
Supplement NumberS011
Date Received02/19/2015
Decision Date03/17/2015
Withdrawal Date11/02/2020
Product Code MAF 
Advisory Committee Cardiovascular
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR A PATIENT IMPLANT CARD.
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