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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 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 NumberS003
Date Received10/31/2000
Decision Date11/20/2000
Product Code MDP 
Advisory Committee Gastroenterology/Urology
Supplement TypeReal-Time Process
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL TO 1) EXPAND THE INSTRUCTIONS FOR USE (IFUS) TO PERMIT THE BLOOD FLOW DIRECTION DURING USE TO BE OPPOSITE TO THE DIRECTION OF FLOW OF THE RINSING AND PRIMING SOLUTIONS, AND TO 2) REMOVE THE BLOOD FLOW DIRECTION ARROW FROM THE DEVICE LABEL.
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