FDA product code SAZ: Stimulator, Nerve Terminus, Totally Implanted For Chronic Intractable Post-Amputation Pain Of The Lower Limb
SAZ is the FDA product code for stimulator, nerve terminus, totally implanted for chronic intractable post-amputation pain of the lower limb. It is a Class III device, reviewed by the Neurology panel. Devices under SAZ reach the market by PMA; FDA lists no cleared 510(k)s for it. 1 PMA application cites this product code.
Definition
As an aid in the management of chronic intractable phantom limb post amputation pain and pain in the residual limb post amputation.
Classification
| Field | Value |
|---|---|
| Device name | Stimulator, Nerve Terminus, Totally Implanted For Chronic Intractable Post-Amputation Pain Of The Lower Limb |
| Device class | Class III |
| Review panel | NE — Neurology |
| Medical specialty | Unknown |
| Premarket route | PMA |
| Implant | Yes |
Recalls for SAZ devices
openFDA lists no recalls for product code SAZ.
Frequently asked questions
What is FDA product code SAZ?
SAZ is the FDA product code for stimulator, nerve terminus, totally implanted for chronic intractable post-amputation pain of the lower limb. It is a Class III device, reviewed by the Neurology panel.
What device class is SAZ?
Class III. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code SAZ
- Run a recall and safety report across every SAZ manufacturer
- Watch product code SAZ 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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