| 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 Code | PBD |
|---|
| 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
Reporting |
Eligible |
| Implanted Device? |
Yes
|
|---|
| Life-Sustain/Support Device? |
No
|
|---|
| Third Party Review |
Not Third Party Eligible |
