|Trade Name||PRISMA TPE 2000 SET|
|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 following modifications to the prisma tpe 2000 set: 1) direct connection of the plasmafilter to the cartridge plate via the dialysate connectors; 2) optimization and simplification of the tubing circuit; 3) the plasmafilter oriented parallel to the cartridge plate; 4) the lines fixed by pawl and ratchet mechanism; 5) the pump segment fixed by clicking via a specific joint connector; and 6) blood lines screwed by connectors to the blood port filter.