| 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. |
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| Device | PROSORBA(TM) COLUMN |
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| Generic Name | Separator, automated, blood cell and plasma, therapeutic |
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| Applicant | FRESENIUS HEMOCARE, INC.
920 WINTER STREET
WALTHAM, MA 02451 |
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| PMA Number | P850020 |
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| Supplement Number | S011 |
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| Date Received | 07/21/1998 |
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| Decision Date | 03/15/1999 |
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Withdrawal Date
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04/14/2008 |
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| Product Code |
LKN |
| Docket Number | 99M-0871 |
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| Notice Date | 04/15/1999 |
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| Advisory Committee |
Gastroenterology/Urology |
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| Supplement Type | Panel Track |
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| Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
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| Expedited Review Granted? | No |
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| Combination Product | No |
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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 |
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| Summary | Summary of Safety and Effectiveness |
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| Labeling | Labeling
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