Product code PBD

Device name

Composite Cultured Skin

Medical specialty

General, Plastic Surgery

Device class

f

Regulation number

878.4024

Review panel

SU

Implant

Y

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Eligible

Definition

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

Source

FDA openFDA device classification dataset