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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.
 
DevicePROSORBA(TM) COLUMN
Generic NameSeparator for therapeutic purposes, membrane automated blood cell/plasma
ApplicantFresenius Hemocare, Inc.
920 Winter St.
Waltham, MA 02451
PMA NumberP850020
Date Received04/02/1985
Decision Date12/23/1987
Withdrawal Date04/14/2008
Product Code MDP 
Docket Number 88M-0019
Notice Date 02/23/1988
Advisory Committee Gastroenterology/Urology
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Supplements:  S003 S004 S005 S006 S008 S009 S011 S012 S013 S014 S015 
S016 S017 S018 S019 S020 S021 S022 S023 S024 
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