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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 NameVERIFLEX (LIBERTE) STENT DELIVERY SYSTEM
Classification Namestent, coronary
Generic Nameintravascular stent with delivery system
ApplicantBOSTON SCIENTIFIC CORPORATION
PMA NumberP040016
Supplement NumberS062
Date Received08/02/2010
Decision Date09/01/2010
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 
Reduction of in-process destructive testing and associated measurements performed on the balloon components of the devices during the balloon molding operation.
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