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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 (TIPS,ILIAC,VENOUS) ENDOPROTHESIS WITH UNISTEP PLUS DELIVERY SYSTEMS
Generic NameSHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS
ApplicantBoston Scientific Corp
One Scimed Pl.
Maple Grove, MN 55311
PMA NumberP930031
Supplement NumberS011
Date Received12/20/2001
Decision Date01/10/2002
Product Code MIR 
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 MANUFACTURING FACILITY LOCATED AT BOSTON SCIENTIFIC IRELAND LTD. (BSIL), GALWAY, IRELAND AND AN ALTERNATE STERILIZATION FACILITY LOCATED AT ISOTRON, OFFALY, IRELAND.
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