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U.S. Department of Health and Human Services

Product Classification

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Device composite cultured skin
Definition For patients with mitten hand deformities due to Recessive Dystrophic Epidermolysis Bullosa (RDEB)
Physical State Composite Cultured Skin (CCS) is an aseptically processed wound dressing composed of a bovine collagen matrix (coated sponge) in which normal human allogeneic skin cells (epidermal keratinocytes and dermal fibroblasts) are cultured in two layers. The device measures approximately 6 cm x 6 cm (minimally 36 cm2).
Technical Method Device fucntions as a phsycia l cover of a autograft wound site. It provdies a mosit wound healign environment and physiological components that interact with the acute wound.
Target Area Wounds created during surgical release of hand contractures (i.e., "mitten" hand deformities).
Regulation Medical Specialty General & Plastic Surgery
Review Panel General & Plastic Surgery
Product CodePBD
Premarket Review Center for Biologics Evaluation & Research (CBER)
Submission Type HDE - Humanitarian Device Exemption
Regulation Number 878.4024
Device Class HDE
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Implanted Device? Yes
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible