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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
ApplicantVantive US Healthcare, LLC
510 Lake Cook Rd.
Deerfield, IL 60015
PMA NumberP830063
Supplement NumberS015
Date Received02/24/2020
Decision Date03/25/2020
Product Code MDP 
Advisory Committee Gastroenterology/Urology
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for the following changes in the instructions for use:1) A labeling change to align the sterile symbol to current sterile fluid path description in the instructions for use of the Prismaflex TPE2000 set; and2) The addition of the following warning statement: Use only drugs compatible with plastics listed in the specifications section. Some plastics can be incompatible with drugs when in contact with solutions with pH > 10.
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