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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
ApplicantVantive US Healthcare, LLC
510 Lake Cook Rd.
Deerfield, IL 60015
PMA NumberP830063
Supplement NumberS010
Date Received10/26/2017
Decision Date11/21/2017
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  
Addition of a new extrusion tubing machine, transfer of the tubing extrusion process, and transfer of the tubing subassembly process to another Baxter facility.
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