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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 NumberS003
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: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Change in the welding process in the manufacture of the device.
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