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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.
 
DevicePROSORBA COLUMN
Generic NameSeparator for therapeutic purposes, membrane automated blood cell/plasma
ApplicantFresenius Hemocare, Inc.
920 Winter St.
Waltham, MA 02451
PMA NumberP850020
Supplement NumberS024
Date Received09/18/2006
Decision Date10/19/2006
Withdrawal Date04/14/2008
Product Code MDP 
Advisory Committee Gastroenterology/Urology
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR LABELING CHANGES TO ADD 1) CAUTION AND PRECAUTION STATEMENTS RELATING TO THE RISK OF THROMBOSIS, 2) A CLARIFICATION REGARDING TREATMENT VOLUMES FOR IDIOPATHIC THROMBOCYTOPENIC PURPURA (ITP) PATIENTS, 3) A CLARIFICATION THAT ITP, AS WELL AS RHEUMATOID ARTHRITIS, PATIENTS MAY NOT FEEL THE EFFECTS OF PROSORBA TREATMENTS IMMEDIATELY AFTER INITIATION OF THERAPY, AND 4) A CLARIFICATION THAT TREATMENTS SHOULD BEGIN WITHIN ONE HOUR OF PRIMING.
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