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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 St.
Waltham, MA 02451
PMA NumberP850020
Supplement NumberS013
Date Received04/30/2001
Decision Date10/26/2001
Withdrawal Date04/14/2008
Product Code LKN 
Advisory Committee Gastroenterology/Urology
Supplement TypeNormal 180 Day 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 REVISED LABELING THAT RELATES NEW POST-MARKET SAFETY INFORMATION REGARDING EPISODES OF VASCULITIS IN RHEUMATOID ARTHRITIS PATIENTS TREATED WITH THE PROSORBA(R) COLUMN.
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