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.
Reduction in the time of the reaction step in the manufacturing process and a decrease in the amount of carbodiimide used in the process.
| Device | PROSORBA COLUMN |
| Generic Name | Separator, Automated, Blood Cell And Plasma, Therapeutic |
| Applicant | FRESENIUS HEMOCARE, INC. |
| Date Received | 2002-04-15 |
| Decision Date | 2002-05-15 |
| PMA | P850020 |
| Supplement | S015 |
| Product Code | LKN |
| Advisory Committee | Gastroenterology/Urology |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| 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 |