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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.
 
DevicePRISMA TPE 2000 SET
Classification Nameseparator for therapeutic purposes, membrane automated blood cell/plasma
Generic Nameseparator for therapeutic purposes, membrane automated blood cell/plasma
Applicant
BAXTER INTERNATIONAL, INC.
1 baxter pkwy.
deerfield, IL 60015-4633
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/material
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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