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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.
 
DevicePRISMAFLEX TPE 2000 Set
Generic NameSeparator for therapeutic purposes, membrane automated blood cell/plasma
ApplicantBAXTER INTERNATIONAL, INC.
1 BAXTER PKWY.
DEERFIELD, IL 60015-4633
PMA NumberP830063
Supplement NumberS016
Date Received03/05/2020
Decision Date05/23/2020
Product Code MDP 
Advisory Committee Gastroenterology/Urology
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for a minor change to the raw material used for the header cap component, which is part of the plasmafilter subassembly of the PRISMAFLEX TPE2000 Set.
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