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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 TIPS ENDOPORSTHESIS
Classification Nameshunt, portosystemic, endoprosthesis
Generic Nameendoprosthesis with unistep plus delivery system
ApplicantBOSTON SCIENTIFIC SCIMED, INC.
PMA NumberP930031
Supplement NumberS025
Date Received05/09/2006
Decision Date06/08/2006
Product Code
MIR[ Registered Establishments with MIR ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: sterilization
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Addition of an alternative biological indicator (bi).
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