FDA product code EZT: Pacemaker, Bladder
EZT is the FDA product code for pacemaker, bladder. It is a Class III device, regulated under 21 CFR 876.5270 and reviewed by the Gastroenterology and Urology panel. Devices under EZT reach the market by PMA; FDA lists no cleared 510(k)s for it.
Definition
Call for PMAs 12/26/96 (61 FR 50707 (9/27/96))
Classification
| Field | Value |
|---|---|
| Device name | Pacemaker, Bladder |
| Device class | Class III |
| Regulation | 21 CFR 876.5270 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | PMA |
| Implant | Yes |
Recalls for EZT devices
openFDA lists no recalls for product code EZT.
Frequently asked questions
What is FDA product code EZT?
EZT is the FDA product code for pacemaker, bladder. It is a Class III device, regulated under 21 CFR 876.5270 and reviewed by the Gastroenterology and Urology panel.
What device class is EZT?
Class III, regulation 21 CFR 876.5270. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code EZT
- Run a recall and safety report across every EZT manufacturer
- Watch product code EZT 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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