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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceGAMBRO FIBER PLASMAFILTER
Generic NameSeparator for therapeutic purposes, membrane automated blood cell/plasma
ApplicantVantive US Healthcare, LLC
510 Lake Cook Rd.
Deerfield, IL 60015
PMA NumberP830063
Date Received10/04/1983
Decision Date05/27/1986
Product Code MDP 
Docket Number 86M-0250
Notice Date 07/07/1986
Advisory Committee Gastroenterology/Urology
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
RecallsCDRH Recalls
Approval Order Statement  
Approval for the Gambro Fiber Plasmafilter PP. This device is indicated for use in performing therapeutic plasma separation from whole blood in a clinical setting to remove circulation plasma components or protein bound toxins.
Supplements:  S001 S002 S003 S004 S005 S006 S007 S008 S009 S010 S012 
S013 S014 S015 S016 S017 S018 S019 S020 S022 S023 S024 S025 
S026 S027 S028 S029 S031 
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