Proper Name: allogeneic cultured keratinocytes and dermal fibroblasts in murine collagen- dsat
Manufacturer: Stratatech Corporation
- For the treatment of adults with thermal burns containing intact dermal elements for which surgical intervention is clinically indicated (deep partial-thickness burns).
- Package Insert - STRATAGRAFT
- Demographic Subgroup Information – allogeneic cultured keratinocytes and dermal fibroblasts in murine collagen- dsat
Refer to Section 1.1 of the Clinical Review Memo for information about participation in the clinical trials and any analysis of demographic subgroup outcomes that is notable.
- June 15, 2021 Approval Letter - STRATAGRAFT
- June 15, 2021 Summary Basis for Regulatory Action - STRATAGRAFT
- Approval History, Letters, Reviews and Related Documents - STRATAGRAFT