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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.
 
DeviceNIRFLEX PREMOUNTED CORONARY STENT SYSTEM
Generic NameSTENT, CORONARY
ApplicantMEDINOL LTD.
KIRYAT ATIDIM, BLDG. 8
POB 58165
TEL-AVIV 61581
PMA NumberP020040
Supplement NumberS007
Date Received10/19/2007
Decision Date05/23/2008
Withdrawal Date 05/30/2014
Product Code MAF 
Advisory Committee Cardiovascular
Supplement Type135 Review Track For 30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR CHANGING THE STERILIZATION LOAD CONFIGURATION AND TEMPERATURE IN THE AERATION CHAMBER FOR NIRFLEX STENTS.
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