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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameWALLSTENT(R) TIPS ENDOPROSTHESIS
Classification Nameshunt, portosystemic, endoprosthesis
Generic Namestent endoprosthesis
ApplicantBOSTON SCIENTIFIC SCIMED, INC.
PMA NumberP930031
Supplement NumberS001
Date Received10/04/1995
Decision Date01/29/1996
Product Code
MIR[ Registered Establishments with MIR ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the addition of 10 mm diameter by 94 mm length wallstent tips (transjugular intrahepatic portosystemic shunt) endoprosthesis.
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