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
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