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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.
 
DeviceEXPRESS/EXPRESS2 MR/OTW CORONARY STENT SYSTEM
Generic NameSTENT, CORONARY
ApplicantBoston Scientific Scimed, Inc.
One Scimed Pl.
Maple Grove, MN 55311
PMA NumberP020009
Supplement NumberS006
Date Received01/30/2003
Decision Date03/12/2003
Withdrawal Date12/06/2018
Product Code MAF 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Express GMP Supplement
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR AN ALTERNATE FACILITY LOCATED AT BOSTON SCIENTIFIC IRELAND, LTD. (BSIL), GALWAY, IRELAND FOR THE MANUFACTURE OF THE STENT COMPONENT OF THE STENT SYSTEM.
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