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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameNIRFLEX PREMOUNTED CORONARY STENT SYSTEM
Classification Namestent, coronary
ApplicantMEDINOL LTD.
PMA NumberP020040
Supplement NumberS007
Date Received11/28/2007
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: sterilization
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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