STN: 125730
Proper Name: allogeneic cultured keratinocytes and dermal fibroblasts in murine collagen- dsat
Tradename: STRATAGRAFT
Manufacturer: Stratatech Corporation
Indication:

• For the treatment of adults with thermal burns containing intact dermal elements for which surgical intervention is clinically indicated (deep partial-thickness burns).

Product Information

• 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.

Supporting Documents

• June 15, 2021 Approval Letter - STRATAGRAFT
• June 15, 2021 Summary Basis for Regulatory Action - STRATAGRAFT
• Approval History, Letters, Reviews and Related Documents - STRATAGRAFT

Related Information

• Press Release - FDA Approves StrataGraft for the Treatment of Adults with Thermal Burns