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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceWALLSTENT ENDO (TIPS) STENT SYSTEM
Classification Nameshunt, portosystemic, endoprosthesis
Generic Nameshunt, portosystemic, endoprosthesis
Applicant
Boston Scientific Corp.
one scimed place
maple grove, MN 55311-1566
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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