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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 AB PLASMAFILTER PF 2000N AND EXCORIM KB MAXO PLASMAFILTER
Generic NameSeparator for therapeutic purposes, membrane automated blood cell/plasma
ApplicantVantive US Healthcare, LLC
510 Lake Cook Rd.
Deerfield, IL 60015
PMA NumberP830063
Supplement NumberS001
Date Received07/06/1995
Decision Date08/28/1996
Product Code MDP 
Advisory Committee Gastroenterology/Urology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR A CHANGE OF MATERIAL USED IN THE HOUSING OF THE DEVICE, END CAP CONFIGURAITON MODIFICATION AND SPECIFICATION CHAGNES TO THE DEVICE MEMBRANE (I.E., DECREASE IN NUMBER OF HOLLOW FIBERS AND INCREASE IN HOLLOW FIBER LENGTH). THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME GAMBRO AB PLASMAFILTER PF 2000N AND EXCORIM KB MAXO PLASMAFILTER AND IS INDICATED FOR USE IN THERAPEUTIC PLASMAFILTRATION IN DISEASES WHERE REMOVAL OF PLASMA COMPONENTS ARE INDICTED, INCLUDING PLASMAFILTRATION PROCEDURESWHERE FILTERED PLASMA IS REINFUSED
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