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 patient brochures for patients with chronic venous insufficiency and diabetic ulcers. The device, as modified, will be marketed under the trade name apligraf and 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 and for use with standard diabetic foot ulcer care for the treatment of full-thickness neuropathic diabetic foot ulcers of greater than three weeks duration which have not adequately responded to conventional ulcer therapy and which extend through the dermis but without tendon, muscle, capsule or bone exposure.
| Device | APLIGRAF(R)(GRAFTSKIN) |
| Classification Name | Dressing, Wound And Burn, Interactive |
| Generic Name | Dressing, Wound And Burn, Interactive |
| Applicant | ORGANOGENESIS, INC. |
| Date Received | 2000-11-03 |
| Decision Date | 2001-11-19 |
| PMA | P950032 |
| Supplement | S019 |
| Product Code | MGR |
| Advisory Committee | General & Plastic Surgery |
| Supplement Type | Real-time Process |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | ORGANOGENESIS, INC. 150 Dan Rd. canton, MA 02021 |
| 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 |