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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceTAXUS EXPRESS PACLITAXEL-ELUTING CORONARY STENT SYSTEM
Generic NameCoronary drug-eluting stent
ApplicantBoston Scientific Corp.
ONE SCIMED PLACE
MAPLE GROVE, MN 55311-1566
PMA NumberP030025
Supplement NumberS093
Date Received04/19/2011
Decision Date07/25/2011
Withdrawal Date 12/06/2018
Product Code NIQ 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track No User Fee
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement  
APPROVAL FOR LABELING CHANGES TO UPDATE THE DIRECTIONS FOR USE TO INCLUDE ADDITIONAL DATA FROM THE TAXUS VISR STUDY.
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