|Trade Name||GAMBRO PRISM TPE 2000 SET WITH PLASMAFILTER PF2000N|
|Classification Name||separator for therapeutic purposes, membrane automated blood cell/plasma|
|Applicant||GAMBRO RENAL PRODUCTS|
|Supplement Type||normal 180 day track|
|Supplement Reason|| change design/components/specifications - component|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for the permanent bonding of tubing lines onto the plasmafilter pf2000n. The device, as modified, will be marketed under the trade name prism tpe 2000 set, and is indicated for use in performing therapeutic plasma separation from whole blood in a clinical setting to remove circulating plasma components or protein bound toxins.