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
| Device Type ID | 230 |
| Device Name | Diaphragmatic/phrenic Nerve Laparoscopically-implanted Stimulator |
| Physical State | Implanted Electrodes, Stimulator Control, Clinical Programming Station |
| Technical Method | Provides Electrical Stimulation For Diaphragm Movement |
| Target Area | Diaphragm |
| Review Panel | Anesthesiology |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID) Respiratory Devices Branch (RPDB) |
| Submission Type | HDE - Humanitarian Device Exem |
| FDA Device Classification | Class HDE Medical Device |
| Product Code | OIR |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | Yes |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 230 |
| Device | Diaphragmatic/phrenic Nerve Laparoscopically-implanted Stimulator |
| Product Code | OIR |
| Device Problems | |
|---|---|
No Pacing | 1 |
| Total Device Problems | 1 |