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.
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).
| Device | 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 |
| Notice Date | 1999-04-15 |
| PMA | P850020 |
| Supplement | S011 |
| Product Code | LKN |
| Docket Number | 99M-0871 |
| Advisory Committee | Gastroenterology/Urology |
| Supplement Type | Panel Track |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | FRESENIUS HEMOCARE, INC. 920 Winter Street waltham, MA 02451 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Approval Order: | Approval Order |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P850020 | Original Filing | |
| S024 | 2006-09-18 | Special (immediate Track) |
| S023 | 2006-04-14 | Special (immediate Track) |
| S022 | 2006-03-31 | Special (immediate Track) |
| S021 | 2005-07-26 | Special (immediate Track) |
| S020 | 2005-07-01 | Normal 180 Day Track No User Fee |
| S019 | 2003-10-17 | Normal 180 Day Track No User Fee |
| S018 | 2003-04-30 | 30-day Notice |
| S017 | 2003-04-15 | Special (immediate Track) |
| S016 | 2002-08-16 | Normal 180 Day Track |
| S015 | 2002-04-15 | 30-day Notice |
| S014 | 2001-08-07 | 30-day Notice |
| S013 | 2001-04-30 | Normal 180 Day Track |
| S012 | 1999-06-21 | Normal 180 Day Track |
| S011 | 1998-07-21 | Panel Track |
| S010 | ||
| S009 | 1997-03-07 | Normal 180 Day Track |
| S008 | 1994-08-12 | Normal 180 Day Track |
| S007 | ||
| S006 | 1993-03-15 | Normal 180 Day Track |
| S005 | 1993-03-09 | Normal 180 Day Track |
| S004 | 1992-02-03 | Normal 180 Day Track |
| S003 | 1990-07-31 | Normal 180 Day Track |
| S002 | ||
| S001 |