Product code
PBD: Composite cultured skin
FDA product code · HDE · General & Plastic Surgery
Key facts
| Product code | PBD |
|---|---|
| Device | Composite cultured skin |
| Device class | HDE |
| Regulation number | 878.4024 |
| Review panel | General & Plastic Surgery |
| Medical specialty | General & Plastic Surgery |
| Submission type | HDE - Humanitarian Device Exemption |
| GMP exempt | No |
| Implanted device | Yes |
| Life-sustaining or life-supporting | No |
| Definition | For patients with mitten hand deformities due to Recessive Dystrophic Epidermolysis Bullosa (RDEB) |
At a glance
- None 510(k) clearances
- None De Novo grants
- None PMA approvals
- 1–9 HDE approvals
- None UDI devices (GUDID)
- None MAUDE adverse event reports
- None Recalled products (Z-numbers)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device product codes
FDA product codes classify medical devices by type and intended use; each code maps to a device class, a classification regulation and a review panel.
Source: U.S. Food and Drug Administration (FDA), Product Classification database