FDA product code PAZ: Electrical Stimulation Bladder System
PAZ is the FDA product code for electrical stimulation bladder system. It is a HDE device, reviewed by the Gastroenterology and Urology panel. Devices under PAZ 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 bowel and are skeletally mature and neurologically stable, to provide bowel evacuation.
Classification
| Field | Value |
|---|---|
| Device name | Electrical Stimulation Bladder System |
| Device class | HDE |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Unknown |
| Premarket route | Unclassified |
| Implant | Yes |
Recalls for PAZ devices
openFDA lists no recalls for product code PAZ.
Frequently asked questions
What is FDA product code PAZ?
PAZ is the FDA product code for electrical stimulation bladder system. It is a HDE device, reviewed by the Gastroenterology and Urology panel.
What device class is PAZ?
HDE. Typical premarket route: Unclassified.
Next steps
- Run an FDA pathway report with predicate devices for product code PAZ
- Run a recall and safety report across every PAZ manufacturer
- Watch product code PAZ 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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