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 several changes to the ra-4 post-approval study protocol. Specifically, these are: 1) a change in inclusion criterion 6 to allow the enrollment of patients who have been on methotrexate (>= 15 mg/week) for at least three months prior to screening, rather than six months prior to screening; 2) the addition of an inclusion criterion to allow the enrollment of patients who have had toxicity to methotrexate at a dose of >= 15 mg/week if they can be on a dose of 12. 5 mg/week; 3) the inclusion of patients receiving concomitant treatment with other disease-modifying anti-rheumatic drugs (dmards); and 4) the inclusion of patients with 12 or more joints tender or painful on motion or pressure, rather than 16 such joints.
| Device | PROSORBA COLUMN |
| Generic Name | Separator, Automated, Blood Cell And Plasma, Therapeutic |
| Applicant | FRESENIUS HEMOCARE, INC. |
| Date Received | 2003-10-17 |
| Decision Date | 2004-04-14 |
| PMA | P850020 |
| Supplement | S019 |
| Product Code | LKN |
| Advisory Committee | Gastroenterology/Urology |
| Supplement Type | Normal 180 Day Track No User Fee |
| Supplement Reason | Postapproval Study Protocol - Ode/oir |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | FRESENIUS HEMOCARE, INC. 920 Winter Street waltham, MA 02451 |
| 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 |