Product code
PSR: Implanted phrenic nerve stimulator for central sleep apnea
FDA product code · Class III · Anesthesiology
Key facts
| Product code | PSR |
|---|---|
| Device | Implanted phrenic nerve stimulator for central sleep apnea |
| Device class | Class III |
| Review panel | Anesthesiology |
| Submission type | PMA |
| GMP exempt | No |
| Implanted device | Yes |
| Life-sustaining or life-supporting | No |
| Definition | The device is intended to stimulate the phrenic nerve to produce diaphragm movement during sleep. |
At a glance
- None 510(k) clearances
- None De Novo grants
- 1–9 PMA approvals
- None HDE approvals
- 10–99 UDI devices (GUDID)
- 10–99 MAUDE adverse event reports
- None Recalled products (Z-numbers)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device product codes
FDA product codes classify medical devices by type and intended use; each code maps to a device class, a classification regulation and a review panel.
Source: U.S. Food and Drug Administration (FDA), Product Classification database