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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceGAMBRO PRISM TPE 2000 SET WITH PLASMAFILTER PF2000N
Generic NameSeparator for therapeutic purposes, membrane automated blood cell/plasma
ApplicantVantive US Healthcare, LLC
510 Lake Cook Rd.
Deerfield, IL 60015
PMA NumberP830063
Supplement NumberS004
Date Received11/13/2001
Decision Date05/10/2002
Product Code MDP 
Advisory Committee Gastroenterology/Urology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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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