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U.S. Department of Health and Human Services

Product Classification

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Device cultured human cell skin dressing
Definition Allogeneic skin cells cultured in vitro and combined with scaffold sheeting to act as a physical wound covering and provide biological components that interact with the wound, for treatment of skin ulcers.
Physical State Allogeneic skin cells are cultured in vitro and combined with scaffold sheeting
Technical Method Device funtions as a physical wound covering and provides biological components that interact with the wound
Target Area Skin
Review Panel General & Plastic Surgery
Product CodePFC
Premarket Review Office of Device Evaluation (ODE)
Division of Surgical Devices (DSD)
Plastic and Reconstructive Surgery Devices Branch Two - Skin/Wound Dressing/Aesthetic Injectables (PRSB2)
Submission Type PMA
Device Class 3
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review Not Third Party Eligible
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