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 a new cell strain, hep 014, for introduction into production of apligraf.
| Device | APLIGRAF |
| Generic Name | Dressing, Wound And Burn, Interactive |
| Applicant | ORGANOGENESIS, INC. |
| Date Received | 2008-09-30 |
| Decision Date | 2008-12-10 |
| PMA | P950032 |
| Supplement | S049 |
| Product Code | MGR |
| Advisory Committee | General & Plastic Surgery |
| Supplement Type | Real-time Process |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | Yes |
| 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 |