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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 OTW PACLITAXEL ELUTING STENT SYSTEM
Generic NameCoronary drug-eluting stent
ApplicantBoston Scientific Corp.
ONE SCIMED PLACE
MAPLE GROVE, MN 55311-1566
PMA NumberP030025
Supplement NumberS058
Date Received08/28/2008
Decision Date09/26/2008
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 ProductNo
Approval Order Statement  
CHANGE TO THE METHOD THAT IS USED TO CREATE THE PROXIMAL MARKS, THREE WHITE CIRCUMFERENTIAL MARKINGS, LOCATED ON THE SHAFT OF THE CATHETER.
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