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 Code | PFC |
Premarket Review |
Center for Biologics Evaluation & Research (CBER)
|
Submission Type |
PMA
|
Device Class |
3
|
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 |