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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 NumberS002
Date Received01/03/2007
Decision Date02/02/2007
Product Code
MAF[ Registered Establishments with MAF ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
CHANGE TO THE ETO LOAD CONFIGURATION FOR STERILIZATION OF THE DEVICE.
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