Definition: The Device Is Intended To Stimulate The Phrenic Nerve To Produce Diaphragm Movement During Sleep.
| Device Type ID | 235 |
| Device Name | Implanted Phrenic Nerve Stimulator For Central Sleep Apnea |
| Physical State | The Device May Include An Implantable Pulse Generator (IPG), Respiratory Sensing And Stimulation Leads. The Device May Also Include External Components Such As A Physician Programmer. |
| Technical Method | The Device Is An Implanted Nerve Stimulator Which Provides Electrical Stimulation Of The Phrenic Nerve In Order To Contract The Diaphragm And Stimulate The Patient To Take A Breath. |
| Target Area | Phrenic Nerve |
| 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 | PMA |
| FDA Device Classification | Class 3 Medical Device |
| Product Code | PSR |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 235 |
| Device | Implanted Phrenic Nerve Stimulator For Central Sleep Apnea |
| Product Code | PSR |
| FDA Device Classification | Class 3 Medical Device |