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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
Classification Namestent, coronary
Generic Namestent, coronary
Applicant
MEDINOL LTD.
kiryat atidim, bldg. 8
pob 58165
tel-aviv 61581
PMA NumberP020040
Supplement NumberS007
Date Received10/19/2007
Decision Date05/23/2008
Product Code
MAF[ Registered Establishments with 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 Product No
Approval Order Statement 
APPROVAL FOR CHANGING THE STERILIZATION LOAD CONFIGURATION AND TEMPERATURE IN THE AERATION CHAMBER FOR NIRFLEX STENTS.
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