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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 may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NamePROSORBA(TM) COLUMN
Classification Nameseparator for therapeutic purposes, membrane automated blood cell/plasma
Generic Nametherapeutic plasma exchange
ApplicantFRESENIUS HEMOCARE, INC.
PMA NumberP850020
Date Received04/02/1985
Decision Date12/23/1987
Withdrawal Date 04/14/2008
Product Code
MDP[ Registered Establishments with MDP ]
Docket Number 88M-0019
Notice Date 02/23/1988
Advisory Committee Gastroenterology/Urology
Expedited Review Granted? No
Combination Product No
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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