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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 NameTAXUS LIBERTE PACLITAXEL-ELUTING STENT SYSTEM (MONORAIL & OVER-THE-WIRE)
Classification Namecoronary drug-eluting stent
ApplicantBOSTON SCIENTIFIC CORPORATION
PMA NumberP060008
Supplement NumberS010
Date Received12/23/2008
Decision Date05/07/2009
Product Code
NIQ[ Registered Establishments with NIQ ]
Advisory Committee Cardiovascular
Supplement Type135 review track for 30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for an additional sterilization chamber at isotron ireland, ltd.
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