|
Device | TRANSCYTE HUMAN FIBROBLAST-DERIVED TEMPORARY SKIN SUBSTITUTE |
Generic Name | Dressing, wound and burn, interactive |
Applicant | SHIRE REGENERATIVE MEDICINE 11095 TORREYANA ROAD SAN DIEGO, CA 92121 |
PMA Number | P960007 |
Date Received | 03/29/1996 |
Decision Date | 03/18/1997 |
Conversion Date
|
08/14/2013 |
Product Code |
MGR |
Docket Number | 98M-0993 |
Notice Date | 12/07/1998 |
Advisory Committee |
General & Plastic Surgery |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement 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 |
Supplements: |
S001 S002 S003 S004 S005 S006 S007 S008 S009 S011 S013 S014 S015 S016 S017 S018 S019 S020 S021 |