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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 TPE2000 Set
Generic NameSeparator for therapeutic purposes, membrane automated blood cell/plasma
ApplicantBAXTER INTERNATIONAL, INC.
1 BAXTER PKWY.
DEERFIELD, IL 60015-4633
PMA NumberP830063
Supplement NumberS012
Date Received06/27/2019
Decision Date09/18/2019
Product Code MDP 
Advisory Committee Gastroenterology/Urology
Supplement TypeReal-Time Process
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for the use of the Prismaflex TPE2000 Set with the PrisMax Control Unit (Version 2) and modifications to the Instructions for Use.
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