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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 NamePRISMAFLEX TPE 2000 SET
Classification Nameseparator for therapeutic purposes, membrane automated blood cell/plasma
Generic Nameplasmafilter
ApplicantGAMBRO RENAL PRODUCTS, INC.
PMA NumberP830063
Supplement NumberS006
Date Received10/16/2007
Decision Date06/17/2011
Product Code
MDP[ Registered Establishments with MDP ]
Advisory Committee Gastroenterology/Urology
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Recalls CDRH Recalls
Approval Order Statement 
Approval for modifications to the gambro prisma tpe 2000 set with plasmafilter pf 2000n to permit the use of the plasmafilter with the gambro prismaflex system. The device, as modified, will be marketed under the trade name prismaflex tpe 2000 set and is indicated for therapeutic plasmapheresis.
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