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 randomized, controlled, within-patient-paired study to compare the effectiveness of transcyte and biobrane in the treatment of mid-dermal to indeterminate depth burn wounds. " this study addresses one of the conditions of approval in the october 17, 1997 agency letter for the indication of partial thickness burns that are mid-dermal to indeterminate depth burn wounds that typically require debridement and that may be expected to heal without autografting. The condition was for a postapproval protocol for a multi-center study utilizing a within patient comparison of dermagraft-tc (transcyte) to a control treatment for partial thickness burns that are mid-dermal to indeterminate depth burn wounds that typically require debridement and that may be expected to heal without autografting. Included in this submission was to be a sample size justification for the number of patients to be evaluated. The endpoints of this study were also to include evaluation of infection rates and rate of patients who go on to require autografting.
| Device | DERMAGRAFT-TC(TM) |
| Classification Name | Dressing, Wound And Burn, Interactive |
| Generic Name | Dressing, Wound And Burn, Interactive |
| Applicant | SHIRE REGENERATIVE MEDICINE |
| Date Received | 1997-11-24 |
| Decision Date | 1999-08-05 |
| PMA | P960007 |
| Supplement | S006 |
| Product Code | MGR |
| Advisory Committee | General & Plastic Surgery |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Other Report |
| 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 |