Product code
OIR: Diaphragmatic/phrenic nerve laparoscopically-implanted stimulator
FDA product code · HDE · Anesthesiology
Key facts
| Product code | OIR |
|---|---|
| Device | Diaphragmatic/phrenic nerve laparoscopically-implanted stimulator |
| Device class | HDE |
| Review panel | Anesthesiology |
| Submission type | HDE - Humanitarian Device Exemption |
| GMP exempt | No |
| Implanted device | Yes |
| Life-sustaining or life-supporting | Yes |
| Definition | The device is intended for use in patients with stable, high spinal cord injuries with stimulatable diaphragms, but who lack control of their diaphragms. The device is indicated to allow the patients to breathe without the assistance of a mechanical ventilator for at least 4 continuous hours a day. For use only in patients 18 years of age or older. |
At a glance
- None 510(k) clearances
- None De Novo grants
- 1–9 PMA approvals
- 1–9 HDE approvals
- 10–99 UDI devices (GUDID)
- 10–99 MAUDE adverse event reports
- 1–9 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