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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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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.
Product CodeOCE
Device Class Humanitarian Device Exemption


Premarket Reviews
ManufacturerDecision
GENZYME CORPORATION
  APPROVED 1

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