FDA product code PBN: Apheresis For Focal Glomerulosclerosis In Adult And Pediatric Patients
PBN is the FDA product code for apheresis for focal glomerulosclerosis in adult and pediatric patients. It is a HDE device, reviewed by the Gastroenterology and Urology panel. Devices under PBN reach the market by Unclassified; FDA lists no cleared 510(k)s for it.
Definition
Removal of plasma components to treat focal glomerulosclerosis
Classification
| Field | Value |
|---|---|
| Device name | Apheresis For Focal Glomerulosclerosis In Adult And Pediatric Patients |
| Device class | HDE |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Unknown |
| Premarket route | Unclassified |
Recalls for PBN devices
openFDA lists no recalls for product code PBN.
Frequently asked questions
What is FDA product code PBN?
PBN is the FDA product code for apheresis for focal glomerulosclerosis in adult and pediatric patients. It is a HDE device, reviewed by the Gastroenterology and Urology panel.
What device class is PBN?
HDE. Typical premarket route: Unclassified.
Next steps
- Run an FDA pathway report with predicate devices for product code PBN
- Run a recall and safety report across every PBN manufacturer
- Watch product code PBN 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.
All Gastroenterology and Urology product codes · FDA product code lookup