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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 NameSTENT, CORONARY
ApplicantBOSTON SCIENTIFIC SCIMED, INC.
ONE SCIMED PLACE
MAPLE GROVE, MN 55311-1566
PMA NumberP020009
Supplement NumberS035
Date Received12/21/2006
Decision Date05/10/2007
Withdrawal Date 12/06/2018
Product Code MAF 
Advisory Committee Cardiovascular
Supplement Type135 Review Track For 30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR AN ALTERNATE METHOD FOR LOADING DIE TEMPERATURE, HEAT TIME, AND PRODUCTION LINE SETTINGS FOR THE DISTAL HEAT SHRINK PROCESS USED IN MANUFACTURING OF THE DEVICES AT THE GALWAY, IRELAND MANUFACTURING SITE.
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