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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™ Delivery System
Generic NameSHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS
ApplicantBoston Scientific Corp
One Scimed Pl.
Maple Grove, MN 55311
PMA NumberP930031
Supplement NumberS074
Date Received09/06/2023
Decision Date02/20/2024
Product Code MIR 
Advisory Committee Cardiovascular
Supplement Type135 Review Track For 30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
an alternate supplier of an ingredient used to make the resin for the tapered tips and luer connector of all Wallstent delivery systems
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