|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 Name||GAMBRO AB PLASMAFILTER PF 2000N AND EXCORIM KB MAXO PLASMAFILTER|
|Classification Name||separator, automated, blood cell and plasma, therapeutic|
|Supplement Type||normal 180 day track|
|Supplement Reason|| change design/components/specifications - other|
|Expedited Review Granted?|| 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.