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 the introduction of human epidermal keratinocyte cellstrain 197 (hep 197) for use in the manufacture of apligraf, and for approval of a change from the current test assay for detection of certain viral contaminants to a real-time pcr method from a conventional gel-based pcr method.
| Device | APLIGRAF |
| Generic Name | Dressing, Wound And Burn, Interactive |
| Applicant | ORGANOGENESIS, INC. |
| Date Received | 2013-04-24 |
| Decision Date | 2013-07-11 |
| PMA | P950032 |
| Supplement | S072 |
| 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 |