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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.
 
DeviceWALLSTENT ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM
Generic NameStent, central venous
ApplicantBOSTON SCIENTIFIC CORPORATION
ONE SCIMED PLACE
MAPLE GROVE, MN 55311-1566
PMA NumberP980033
Supplement NumberS008
Date Received11/17/2003
Decision Date12/11/2003
Product Code QKJ 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE ADDITION OF TWO MANUFACTURING FACILITIES LOCATED AT BOSTON SCIENTIFIC CORP., QUINCY, MASSACHUSETTS AND BOSTON SCIENTIFIC EUROPEAN DISTRIBUTION CENTER, MAASTRICHT-AIRPORT, THE NETHERLANDS. THESE FACILITIES WILL PERFORM PACKAGING AND LABELING OPERATIONS FOR THE WALLSTENT ENDOPROSTHESIS WITH THE UNISTEP PLUS DELIVERY SYSTEM.
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