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(r). The device is indicated for use in the treatment of full-thickness diabetic foot ulcers greater than six weeks duration which extend through the dermis, but without tendon muscle, joint capsule or bone exposure. Dermagraft(r) should be used in conjunction with standard wound care regimens and in patients that have adequate blood supply to the involved foot.
| Device | DERMAGRAFT |
| Generic Name | Dressing, Wound And Burn, Interactive |
| Applicant | SHIRE REGENERATIVE MEDICINE |
| Date Received | 2000-08-25 |
| Decision Date | 2001-09-28 |
| Notice Date | 2001-10-31 |
| PMA | P000036 |
| Supplement | S |
| Product Code | MGR |
| Docket Number | 01M-0498 |
| Advisory Committee | General & Plastic Surgery |
| Expedited Review | No |
| Combination Product | Yes |
| Applicant Address | SHIRE REGENERATIVE MEDICINE 11095 Torreyana Road san Diego, CA 92121 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Approval Order: | Approval Order |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P000036 | Original Filing | |
| S018 | 2013-04-25 | 30-day Notice |
| S017 | 2013-04-24 | 30-day Notice |
| S016 | 2013-04-23 | 30-day Notice |
| S015 | ||
| S014 | 2012-12-21 | 135 Review Track For 30-day Notice |
| S013 | 2012-06-29 | 30-day Notice |
| S012 | 2012-06-05 | 30-day Notice |
| S011 | 2012-04-23 | 135 Review Track For 30-day Notice |
| S010 | 2012-03-16 | 30-day Notice |
| S009 | 2012-03-16 | 30-day Notice |
| S008 | 2012-03-13 | Normal 180 Day Track No User Fee |
| S007 | 2010-03-02 | 30-day Notice |
| S006 | 2008-10-31 | 30-day Notice |
| S005 | ||
| S004 | ||
| S003 | 2003-11-17 | Special (immediate Track) |
| S002 | 2002-03-05 | Special (immediate Track) |
| S001 |