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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 TIPS Endoprosthesis with UNISTEP Plus
Generic NameSHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS
ApplicantBoston Scientific Corp.
ONE SCIMED PLACE
MAPLE GROVE, MN 55311-1566
PMA NumberP930031
Supplement NumberS063
Date Received03/22/2019
Decision Date04/17/2019
Product Code MIR 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Add an existing EO sterilization cycle to an additional chamber in order to increase cycle capacity.
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