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U.S. Department of Health and Human Services

Product Classification

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Device cultured epithelial autograft
Definition Interactive wound and burn dressing containing a live xenogeneic component. Indicated for use in patients who have deep dermal or full thickness burns comprising a total body surface area of greater than or equal to 30%. It may be used in conjunction with split-thickness autografts, or alone in patients for whom split-thickness autografts may not be an option due to the severity and extent of their burns.
Physical State Epicel cultured epidermal autografts (CEA) is an aseptically processed wound dressing composed of the patient?s own (autologous) keratinocytes grown ex vivo in the presence of proliferation-arrested, murine (mouse) fibroblasts. Epicel consists of sheets of proliferative, autologous keratinocytes, ranging from 2 to 8 cell layers thick and is referred to as a cultured epidermal autograft. Each graft of Epicel is attached to petrolatum gauze backing with stainless steel surgical clips and measures approximately 50 cm2 in area.
Technical Method Patient's own cells are in vitro cultivated and expanded in number into a graft/dressing design in sufficient size to facilitate coverage of the burn injury.
Target Area Entire integumentary (skin) system
Review Panel General & Plastic Surgery
Product CodeOCE
Premarket Review Center for Biologics Evaluation & Research (CBER)
Submission Type HDE - Humanitarian Device Exemption
Device Class HDE
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Implanted Device? Yes
Life-Sustain/Support Device? Yes
Third Party Review Not Third Party Eligible