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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 NumberS004
Date Received05/05/2014
Decision Date06/02/2014
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  
SHORTENING OF THE SUPPLY CHAIN FOR THE NYLON 12 RAW MATERIAL USED IN THE COATING OF A COMPONENT OF THE D-CATHETER DELIVERY SYSTEM.
Post-Approval StudyShow Report Schedule and Study Progress
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