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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.
 
DeviceGambro Prismaflex TPE 2000 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 NumberS023
Date Received03/29/2022
Decision Date04/07/2022
Product Code MDP 
Advisory Committee Gastroenterology/Urology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Transfer of the manufacturing process of the twin tube component of the Prismaflex TPE2000 set to an in-house supplier.
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