PBD

Composite Cultured Skin

Product code

PBD

Device name

Composite Cultured Skin

Device class

Class F

21 CFR

21 CFR 878.4024

Medical specialty

General, Plastic Surgery

Marketing pathway

HDE - Humanitarian Device Exemption

Flag

Implant

FDA classification definition

For patients with mitten hand deformities due to Recessive Dystrophic Epidermolysis Bullosa (RDEB)

Definition text from the FDA device classification database (U.S. federal government work, public domain).