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 add 1) caution and precaution statements relating to the risk of thrombosis, 2) a clarification regarding treatment volumes for idiopathic thrombocytopenic purpura (itp) patients, 3) a clarification that itp, as well as rheumatoid arthritis, patients may not feel the effects of prosorba treatments immediately after initiation of therapy, and 4) a clarification that treatments should begin within one hour of priming.
Device | PROSORBA COLUMN |
Generic Name | Separator For Therapeutic Purposes, Membrane Automated Blood Cell/plasma |
Applicant | FRESENIUS HEMOCARE, INC. |
Date Received | 2006-09-18 |
Decision Date | 2006-10-19 |
PMA | P850020 |
Supplement | S024 |
Product Code | MDP |
Advisory Committee | Gastroenterology/Urology |
Supplement Type | Special (immediate 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 |
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 |