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.
Approval for the dermagraft-tc(tm). The device is indicated for use as a temporary wound covering for surgically excised full-thickness and deep partial-thickness thermal burn wounds in patients who require such a covering prior to autograft placement
| Device | TRANSCYTE HUMAN FIBROBLAST-DERIVED TEMPORARY SKIN SUBSTITUTE |
| Classification Name | Dressing, Wound And Burn, Interactive |
| Generic Name | Dressing, Wound And Burn, Interactive |
| Applicant | SHIRE REGENERATIVE MEDICINE |
| Date Received | 1996-03-29 |
| Decision Date | 1997-03-18 |
| Notice Date | 1998-12-07 |
| PMA | P960007 |
| Supplement | S |
| Product Code | MGR |
| Docket Number | 98M-0993 |
| Advisory Committee | General & Plastic Surgery |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | SHIRE REGENERATIVE MEDICINE 11095 Torreyana Road san Diego, CA 92121 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P960007 | Original Filing | |
| S021 | 2011-03-07 | Normal 180 Day Track |
| S020 | 2010-11-01 | 135 Review Track For 30-day Notice |
| S019 | 2010-07-26 | 30-day Notice |
| S018 | 2003-11-17 | Special (immediate Track) |
| S017 | 2002-08-22 | Normal 180 Day Track No User Fee |
| S016 | 2001-11-05 | Real-time Process |
| S015 | 2001-06-26 | Normal 180 Day Track |
| S014 | 2000-03-01 | Normal 180 Day Track |
| S013 | 1999-09-02 | Normal 180 Day Track |
| S012 | ||
| S011 | 1999-08-19 | Normal 180 Day Track |
| S010 | ||
| S009 | 1998-07-24 | Normal 180 Day Track |
| S008 | 1998-07-10 | Normal 180 Day Track |
| S007 | 1998-01-09 | Normal 180 Day Track |
| S006 | 1997-11-24 | Normal 180 Day Track |
| S005 | 1997-10-29 | Normal 180 Day Track |
| S004 | 1997-10-21 | Real-time Process |
| S003 | 1997-10-22 | Normal 180 Day Track |
| S002 | 1997-05-05 | Real-time Process |
| S001 | 1997-04-08 | Real-time Process |