FDA product code PSR: Implanted Phrenic Nerve Stimulator For Central Sleep Apnea
PSR is the FDA product code for implanted phrenic nerve stimulator for central sleep apnea. It is a Class III device, reviewed by the Anesthesiology panel. Devices under PSR reach the market by PMA; FDA lists no cleared 510(k)s for it. 1 PMA application cites this product code.
Definition
The device is intended to stimulate the phrenic nerve to produce diaphragm movement during sleep.
Classification
| Field | Value |
|---|---|
| Device name | Implanted Phrenic Nerve Stimulator For Central Sleep Apnea |
| Device class | Class III |
| Review panel | AN — Anesthesiology |
| Medical specialty | Unknown |
| Premarket route | PMA |
| Implant | Yes |
Recalls for PSR devices
openFDA lists no recalls for product code PSR.
Frequently asked questions
What is FDA product code PSR?
PSR is the FDA product code for implanted phrenic nerve stimulator for central sleep apnea. It is a Class III device, reviewed by the Anesthesiology panel.
What device class is PSR?
Class III. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code PSR
- Run a recall and safety report across every PSR manufacturer
- Watch product code PSR 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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