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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) BARE METAL CORONARY STENT SYSTEM
Classification Namestent, coronary
Generic Nameintravascular stent with delivery system
ApplicantBOSTON SCIENTIFIC CORPORATION
PMA NumberP040016
Supplement NumberS069
Date Received12/22/2010
Decision Date09/23/2011
Product Code
MAF[ Registered Establishments with MAF ]
Advisory Committee Cardiovascular
Supplement Type135 review track for 30-day notice
Supplement Reason process change - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval to update the gel rating specification scale used for resin material acceptance.
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