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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 STENT SYSTEM
Generic NameCoronary drug-eluting stent
ApplicantBoston Scientific Corp
One Scimed Pl.
Maple Grove, MN 55311
PMA NumberP030025
Supplement NumberS055
Date Received04/21/2008
Decision Date05/21/2008
Withdrawal Date12/06/2018
Product Code NIQ 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
CHANGE TO A TEST METHOD AND CORRESPONDING SPECIFICATIONS FOR THE TENSILE PROPERTY OF THE BALLOON TUBE COMPONENT.
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