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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 NumberS030
Date Received12/12/2025
Decision Date03/13/2026
Product Code MDP 
Advisory Committee Gastroenterology/Urology
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Extend Prismaflex TPE2000 Set EO sterilization to STERLAB new supplier (scope of the P830063/A013 notification) for the Chambers #11 and #14, increase the sterilization load by changing palletization configuration from 4 layers of boxes to 5 layers of boxes per pallet at STERLAB, and qualify a new EO supplier STERISERVICES, for the Chamber ATC011
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