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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
ApplicantBOSTONSCIENTIFIC
PMA NumberP030025
Supplement NumberS011
Date Received11/02/2004
Decision Date11/11/2004
Product Code
NIQ[ Registered Establishments with NIQ ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change - other
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Change in the bacterial endotoxin test used as part of the finished device testing.
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