PBD — Composite Cultured Skin Class f
FDA product code PBD covers "Composite Cultured Skin", a Class f medical device regulated under 21 CFR 878.4024. Submissions are reviewed by the General, Plastic Surgery panel. Devices under this code are implants.
Classification Details
- Product Code
- PBD
- Device Class
- Class f
- Regulation Number
- 878.4024
- Submission Type
- Review Panel
- SU
- Medical Specialty
- General, Plastic Surgery
- Implant
- Yes
Definition
For patients with mitten hand deformities due to Recessive Dystrophic Epidermolysis Bullosa (RDEB)