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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameWALLSTENT(R) TIPS ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM
Classification Nameshunt, portosystemic, endoprosthesis
Generic Namestent endoprosthesis
ApplicantBOSTON SCIENTIFIC CORP.
PMA NumberP930031
Date Received09/20/1993
Decision Date09/29/1995
Product Code
MIR[ Registered Establishments with MIR ]
Docket Number 96M-0238
Notice Date 07/17/1996
Advisory Committee Cardiovascular
Expedited Review Granted? Yes
Combination Product No
Approval Order Statement 
Approval for the wallstent tips (transjugular intrahepatic portosystemic shunt) endoprosthesis.
Supplements: S001 S002 S003 S004 S005 S006 S007 S009 S010 
S011 S012 S013 S014 S015 S016 S017 S018 S020 
S021 S022 S023 S024 S025 S026 S027 S028 S029 
S030 S031 S032 S033 S034 S035 S036 S037 S038 
S039 S040 S041 S042 S043 S044 S045 S046 S047 
S048 S049 S050 S051 
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