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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 NumberS004
Date Received01/16/2007
Decision Date02/15/2007
Product Code
MAF[ Registered Establishments with MAF ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Change to the pcd configuration used during the eto sterilization process and removal timing for the incubation of the bis used during the eto sterilization process.
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