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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 ENDO (TIPS) STENT SYSTEM
Classification Nameshunt, portosystemic, endoprosthesis
Generic Nameendoprosthesis with unistep plus delivery system
ApplicantBOSTON SCIENTIFIC CORPORATION
PMA NumberP930031
Supplement NumberS037
Date Received10/15/2012
Decision Date10/31/2012
Product Code
MIR[ Registered Establishments with MIR ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Alternate inspection equipment for the extruded tubing component.
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