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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameGAMBRO AB PLASMAFILTER PF 2000N AND EXCORIM KB MAXO PLASMAFILTER
Classification Nameseparator, automated, blood cell and plasma, therapeutic
Generic Nameplasmafilter
ApplicantGAMBRO, INC.
PMA NumberP830063
Supplement NumberS001
Date Received07/06/1995
Decision Date08/28/1996
Product Code
LKN[ Registered Establishments with LKN ]
Advisory Committee Gastroenterology/Urology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
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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