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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 TRANSJUGULAR INTRAHEPATIC PORTOSYSTEMIC SHUNT (TIPS) ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM
Classification Nameshunt, portosystemic, endoprosthesis
Generic Nameendoprosthesis with unistep plus delivery system
ApplicantBOSTON SCIENTIFIC CORP.
PMA NumberP930031
Supplement NumberS026
Date Received11/19/2008
Decision Date12/16/2008
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 
Change in the sterile load configuration and the sterilization load density of the cycle used by the devices.
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