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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 NameGAMBRO PRISM TPE 2000 SET WITH PLASMAFILTER PF2000N
Classification Nameseparator, automated, blood cell and plasma, therapeutic
Generic Nameplasmafilter
ApplicantGAMBRO RENAL PRODUCTS
PMA NumberP830063
Supplement NumberS004
Date Received11/13/2001
Decision Date05/10/2002
Product Code
LKN[ Registered Establishments with LKN ]
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 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.
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