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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.
 
DeviceEXPRESS2 CORONARY STENT SYSTEM
Generic NameSTENT, CORONARY
ApplicantBOSTON SCIENTIFIC SCIMED, INC.
ONE SCIMED PLACE
MAPLE GROVE, MN 55311-1566
PMA NumberP020009
Supplement NumberS033
Date Received09/21/2006
Decision Date02/12/2007
Withdrawal Date 12/06/2018
Product Code MAF 
Advisory Committee Cardiovascular
Supplement Type135 Review Track For 30-Day Notice
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL TO ADD AN AUTOMATED STENT INSPECTION STEP FOR THE STENT COMPONENT OF THE DEVICE.
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