FDA product code PBD: Composite Cultured Skin
PBD is the FDA product code for composite cultured skin. It is a HDE device, regulated under 21 CFR 878.4024 and reviewed by the General and Plastic Surgery panel. Devices under PBD reach the market by Unclassified; FDA lists no cleared 510(k)s for it.
Definition
For patients with mitten hand deformities due to Recessive Dystrophic Epidermolysis Bullosa (RDEB)
Classification
| Field | Value |
|---|---|
| Device name | Composite Cultured Skin |
| Device class | HDE |
| Regulation | 21 CFR 878.4024 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | Unclassified |
| Implant | Yes |
Recalls for PBD devices
openFDA lists no recalls for product code PBD.
Frequently asked questions
What is FDA product code PBD?
PBD is the FDA product code for composite cultured skin. It is a HDE device, regulated under 21 CFR 878.4024 and reviewed by the General and Plastic Surgery panel.
What device class is PBD?
HDE, regulation 21 CFR 878.4024. Typical premarket route: Unclassified.
Next steps
- Run an FDA pathway report with predicate devices for product code PBD
- Run a recall and safety report across every PBD manufacturer
- Watch product code PBD for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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