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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 (MONORAIL AND OVER-THE-WIRE)
Classification Namecoronary drug-eluting stent
Generic Nameintravascular stent with delivery system
ApplicantBOSTON SCIENTIFIC CORPORATION
PMA NumberP030025
Supplement NumberS013
Date Received11/17/2004
Decision Date10/19/2006
Product Code
NIQ[ Registered Establishments with NIQ ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track no user fee
Supplement Reason postapproval protocol or modification to a protocol
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for a revision particulate testing method and revising regulatory and batch release particulate specifications.
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