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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 EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM
Classification Namecoronary drug-eluting stent
Generic Nameintravascular stent with delivery system
ApplicantBOSTON SCIENTIFIC CORP.
PMA NumberP030025
Supplement NumberS059
Date Received09/29/2008
Decision Date03/20/2009
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 changes to the size of the sibs pieces and the process for mixing and filtering the spray coating solution used to manufacture the device.
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