FDA product code PAT: Bladder System
PAT is the FDA product code for bladder system. It is a HDE device, reviewed by the Gastroenterology and Urology panel. Devices under PAT reach the market by Unclassified; FDA lists no cleared 510(k)s for it.
Definition
for the treatment of patients who have complete spinal cord lesions (ASIA Classification) with intact parasympathetic innervation of the bladder and are skeletally mature and neurologically stable, to provide urination on demand and to reduce post-void residual volumes of urine.
Classification
| Field | Value |
|---|---|
| Device name | Bladder System |
| Device class | HDE |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Unknown |
| Premarket route | Unclassified |
| Implant | Yes |
Recalls for PAT devices
openFDA lists no recalls for product code PAT.
Frequently asked questions
What is FDA product code PAT?
PAT is the FDA product code for bladder system. It is a HDE device, reviewed by the Gastroenterology and Urology panel.
What device class is PAT?
HDE. Typical premarket route: Unclassified.
Next steps
- Run an FDA pathway report with predicate devices for product code PAT
- Run a recall and safety report across every PAT manufacturer
- Watch product code PAT 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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