PMA P850020S011
- Device
- PROSORBA(TM) COLUMN
- Applicant
- Fresenius Hemocare, Inc.
- PMA number
- P850020
- Supplement
- S011
- Product code
- LKN
- Decision date
- 1999-03-15
- Generic name
- Separator, automated, blood cell and plasma, therapeutic
- 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).
- Summary
- <a href="http://www.accessdata.fda.gov/cdrh_docs/pdf/P850020S011B.pdf" target="_new">Summary of Safety and Effectiveness</a>
Current openFDA PMA Record#
- Device
- PROSORBA(TM) COLUMN
- Applicant
- Fresenius Hemocare, Inc.
- PMA number
- P850020
- Supplement
- S011
- Product code
- LKN
- Generic name
- Separator, automated, blood cell and plasma, therapeutic
- Decision date
- 1999-03-15
- Decision code
- APPR
- Date received
- 1998-07-21
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- 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).