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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 NamePRISMA TPE 2000 SET
Classification Nameseparator for therapeutic purposes, membrane automated blood cell/plasma
Generic Nameplasmafilter
ApplicantGAMBRO RENAL PRODUCTS
PMA NumberP830063
Supplement NumberS005
Date Received11/24/2006
Decision Date06/19/2009
Product Code
MDP[ Registered Establishments with MDP ]
Advisory Committee Gastroenterology/Urology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product 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.
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