PROSORBA(TM) COLUMN
FDA premarket approval P850020/S011 · decided 1999-03-15
Approval details
- PMA number
- P850020
- Supplement
- S011
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- PROSORBA(TM) COLUMN
- Generic name
- Separator, automated, blood cell and plasma, therapeutic
- Applicant
- Fresenius Hemocare, Inc.
- Date received
- 1998-07-21
- Decision date
- 1999-03-15
- Days to decision
- 237 days
- Decision code
- APPR
- Product code
- LKN
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Waltham, MA
- 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-m
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