This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.
This device is indicated for use with standard therapeutic compression for the treatment of non-infected partial and full-thickness skin ulcers due to venous insufficiency of greater than 1 month duration and which have not adequately responded to conventional ulcer therapy.
| Device | APLIGRAF (GRAFTSKIN) |
| Classification Name | Dressing, Wound And Burn, Interactive |
| Generic Name | Dressing, Wound And Burn, Interactive |
| Applicant | ORGANOGENESIS, INC. |
| Date Received | 1995-10-04 |
| Decision Date | 1998-05-22 |
| Notice Date | 1998-12-17 |
| PMA | P950032 |
| Supplement | S |
| Product Code | MGR |
| Docket Number | 98M-0992 |
| Advisory Committee | General & Plastic Surgery |
| Expedited Review | Yes |
| Combination Product | Yes |
| Applicant Address | ORGANOGENESIS, INC. 150 Dan Rd. canton, MA 02021 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Approval Order: | Approval Order |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P950032 | Original Filing | |
| S074 | 2013-07-19 | 30-day Notice |
| S073 | 2013-05-21 | Normal 180 Day Track No User Fee |
| S072 | 2013-04-24 | Real-time Process |
| S071 | 2012-12-18 | Real-time Process |
| S070 | 2012-12-13 | 135 Review Track For 30-day Notice |
| S069 | 2012-10-31 | Real-time Process |
| S068 | 2012-03-07 | Real-time Process |
| S067 | 2012-02-01 | Real-time Process |
| S066 | 2011-12-19 | Real-time Process |
| S065 | 2011-10-27 | 30-day Notice |
| S064 | 2011-08-05 | Real-time Process |
| S063 | 2011-03-01 | Real-time Process |
| S062 | 2011-01-11 | 30-day Notice |
| S061 | 2010-12-08 | Special (immediate Track) |
| S060 | 2010-09-22 | Real-time Process |
| S059 | 2010-07-01 | 135 Review Track For 30-day Notice |
| S058 | 2010-06-10 | Real-time Process |
| S057 | 2010-03-11 | 30-day Notice |
| S056 | 2010-02-12 | Real-time Process |
| S055 | 2009-11-23 | 30-day Notice |
| S054 | 2009-11-13 | Real-time Process |
| S053 | 2009-08-04 | 30-day Notice |
| S052 | 2009-06-18 | Real-time Process |
| S051 | 2009-04-09 | Real-time Process |
| S050 | 2009-02-11 | 30-day Notice |
| S049 | 2008-09-30 | Real-time Process |
| S048 | 2008-06-17 | 30-day Notice |
| S047 | 2008-04-14 | 30-day Notice |
| S046 | 2008-03-10 | Special (immediate Track) |
| S045 | 2007-10-29 | Real-time Process |
| S044 | 2007-05-15 | Real-time Process |
| S043 | 2006-03-02 | Real-time Process |
| S042 | ||
| S041 | 2005-05-26 | 30-day Notice |
| S040 | 2005-04-04 | 30-day Notice |
| S039 | ||
| S038 | 2004-05-26 | Real-time Process |
| S037 | 2003-12-24 | 30-day Notice |
| S036 | 2003-09-30 | 30-day Notice |
| S035 | 2003-08-18 | 30-day Notice |
| S034 | 2002-08-05 | Normal 180 Day Track |
| S033 | 2002-07-16 | 30-day Notice |
| S032 | 2002-06-12 | Real-time Process |
| S031 | 2002-03-25 | Real-time Process |
| S030 | ||
| S029 | 2002-02-04 | Real-time Process |
| S028 | 2001-10-24 | Normal 180 Day Track |
| S027 | 2001-10-15 | Real-time Process |
| S026 | 2001-08-15 | 30-day Notice |
| S025 | 2001-07-19 | Real-time Process |
| S024 | 2001-06-18 | 30-day Notice |
| S023 | 2001-04-30 | Real-time Process |
| S022 | 2001-01-17 | Normal 180 Day Track |
| S021 | 2000-11-21 | 30-day Notice |
| S020 | 2000-11-09 | Normal 180 Day Track |
| S019 | 2000-11-03 | Real-time Process |
| S018 | 2000-08-08 | Real-time Process |
| S017 | 2000-03-07 | Real-time Process |
| S016 | 1999-12-23 | Normal 180 Day Track |
| S015 | 1999-09-03 | 30-day Notice |
| S014 | 1999-09-02 | Real-time Process |
| S013 | ||
| S012 | ||
| S011 | 1999-04-27 | Real-time Process |
| S010 | 1999-04-14 | Normal 180 Day Track |
| S009 | 1999-03-25 | 30-day Notice |
| S008 | 1998-12-04 | Normal 180 Day Track |
| S007 | 1998-11-27 | Normal 180 Day Track |
| S006 | ||
| S005 | ||
| S004 | 1998-10-28 | Normal 180 Day Track |
| S003 | ||
| S002 | 1998-06-30 | Normal 180 Day Track |
| S001 | 1998-06-17 | 30-day Notice |