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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 EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM
Generic NameCoronary drug-eluting stent
ApplicantBoston Scientific Corp.
ONE SCIMED PLACE
MAPLE GROVE, MN 55311-1566
PMA NumberP030025
Supplement NumberS011
Date Received11/02/2004
Decision Date11/11/2004
Withdrawal Date 12/06/2018
Product Code NIQ 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement  
CHANGE IN THE BACTERIAL ENDOTOXIN TEST USED AS PART OF THE FINISHED DEVICE TESTING.
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