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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.
Classification Nameseparator, automated, blood cell and plasma, therapeutic
Generic Nameseparator, automated, blood cell and plasma, therapeutic
920 winter street
waltham, MA 02451
PMA NumberP850020
Supplement NumberS011
Date Received07/21/1998
Decision Date03/15/1999
Product Code
LKN[ Registered Establishments with LKN ]
Docket Number 99M-0871
Notice Date 04/15/1999
Advisory Committee Gastroenterology/Urology
Supplement Typepanel track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Recalls CDRH Recalls
Approval Order Statement 
Approval for the Prosorba(R) Column. This device is indicated for: 1) use in the therapeutic removal of immunoglobulin G (IgG) and IgG-containting circulating immune complexes from plasma in patients with idiopathic thrombocytopenic purpura (ITP) having platelet counts less than 100,000mm3 and 2) for use in the therapeutic reduction of the signs and symptoms of moderate to severe rheumatoid arthritis (RA) in adult patients with long-standing disease who have failed or are intolerant to disease-modifying anti-rheumatic drugs (DMARDs).
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling