STRATAGRAFT

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

Indication

• To promote durable wound closure & regenerative healing in the treatment of adult patients with debrided thermal burns that contain intact dermal elements, and for which surgical intervention is clinically indicated.

Product Information

• Package Insert - STRATAGRAFT
• Patient Information - 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

• January 30, 2024 Approval Letter - STRATAGRAFT
• 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