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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 PRISMA TPE 2000 SET WITH PLASMAFILTER PF2000N
Classification Nameseparator for therapeutic purposes, membrane automated blood cell/plasma
Generic Nameplasmafilter
ApplicantGAMBRO RENAL PRODUCTS
PMA NumberP830063
Supplement NumberS002
Date Received01/18/2000
Decision Date08/28/2002
Product Code
MDP[ Registered Establishments with MDP ]
Advisory Committee Gastroenterology/Urology
Supplement Typenormal 180 day track
Supplement Reason other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for modifications to the requirements of the post-market study for the device.
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