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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 PRISMA 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 NumberS002
Date Received01/18/2000
Decision Date08/28/2002
Product Code MDP 
Advisory Committee Gastroenterology/Urology
Supplement TypeNormal 180 Day Track
Supplement Reason Other
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR MODIFICATIONS TO THE REQUIREMENTS OF THE POST-MARKET STUDY FOR THE DEVICE.
Post-Approval StudyShow Report Schedule and Study Progress
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