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
| Device Type ID | 5955 |
| Device Name | Cultured Epithelial Autograft |
| 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 She |
| 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 |
| 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 | HDE - Humanitarian Device Exem |
| FDA Device Classification | Class HDE Medical Device |
| Product Code | OCE |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | Yes |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5955 |
| Device | Cultured Epithelial Autograft |
| Product Code | OCE |