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 change in the caution statement in the directions for use from "do not use dermagraft after the expiration date" to "do not use dermagraft after the expiration date indicated on the labeled unit carton. "
| Device | DERMAGRAFT |
| Generic Name | Dressing, Wound And Burn, Interactive |
| Applicant | SHIRE REGENERATIVE MEDICINE |
| Date Received | 2002-03-05 |
| Decision Date | 2002-03-19 |
| PMA | P000036 |
| Supplement | S002 |
| Product Code | MGR |
| Advisory Committee | General & Plastic Surgery |
| Supplement Type | Special (immediate Track) |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | SHIRE REGENERATIVE MEDICINE 11095 Torreyana Road san Diego, CA 92121 |
| 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 |