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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  S006 S003 S004 S009 S013 S002 S005 S017 S012 S025 
S018 S024 S026 S029 S010 S032 S008 S007 S014 S015 S016 S019 
S030 S031 S020 S022 S023 S027 S028 
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