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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(R) ILIAC ENDOPROSTHESIS
Generic NameSHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS
ApplicantBOSTON SCIENTIFIC SCIMED, INC.
ONE SCIMED PLACE
MAPLE GROVE, MN 55311-1566
PMA NumberP940019
Supplement NumberS002
Date Received10/15/1996
Decision Date04/14/1997
Product Code MIR 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR AN ALTERNATE DELIVERY SYSTEM FOR THE WALLSTENT(TM) ILIAC ENDOPROSTHESIS (THE UNISTEP(TM) PLUS DELIVERY SYSTEM)
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