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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 NumberS012
Date Received08/07/2015
Decision Date09/03/2015
Withdrawal Date 11/02/2020
Product Code MAF 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
CHANGE TO DECREASE THE CRIMPING AND PRE-CRIMPING FORCES IN THE 3.5X 24MM AND 4.0 X 08MM STENT SIZES.
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