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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, automated, blood cell and plasma, therapeutic
ApplicantFRESENIUS HEMOCARE, INC.
920 WINTER STREET
WALTHAM, MA 02451
PMA NumberP850020
Supplement NumberS017
Date Received04/15/2003
Decision Date04/15/2004
Withdrawal Date 04/14/2008
Product Code LKN 
Advisory Committee Gastroenterology/Urology
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR LABELING CHANGES TO 1) ADD A PRECAUTION ABOUT THE USE OF PEDIATRIC ASPIRIN FOR RHEUMATOID ARTHRITIS (RA) PATIENTS DUE TO THE INCREASES RISK OF THROMBOSIS, AND 2) SPECIFY THE TREATMENT REGIMEN FOR IDIOPATHIC THROMBOCYTOPENIC PURPURA (ITP) PATIENTS SO THAT PATIENTS RECEIVE 6 TREATMENTS, 2-3 TIMES A WEEK FOR 2 OR 3 WEEKS.
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