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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.
 
DeviceVERIFLEX (LIBERTE) CORONARY STENT SYSTEM
Classification Namestent, coronary
Generic Namestent, coronary
Applicant
BOSTON SCIENTIFIC SCIMED, INC.
one scimed place
maple grove, MN 55311
PMA NumberP040016
Supplement NumberS118
Date Received11/25/2013
Decision Date12/20/2013
Product Code
MAF[ Registered Establishments with MAF ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Changes to the in-process endotoxin testing during component manufacturing.
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