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 labeling changes to the package insert (i. E. , revisions to the sections entitled column preparation, off-line procedure and on-line procedure, including more detailed instructions for use, illustrations of the device set-up, increased patient monitoring and refinement of specified plasma flow rates) and a procedure change involving the use of an "in-line" leukocyte removal filtr for microaggregate removal which is to be inserted in te blood line returning treated plasma to the patient
| Device | PROSORBA(TM) COLUMN |
| Generic Name | Separator, Automated, Blood Cell And Plasma, Therapeutic |
| Applicant | FRESENIUS HEMOCARE, INC. |
| Date Received | 1994-08-12 |
| Decision Date | 1996-09-27 |
| PMA | P850020 |
| Supplement | S008 |
| Product Code | LKN |
| Advisory Committee | Gastroenterology/Urology |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| 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 |