Definition: Deep Brain Stimulation For The Treatment Of Essential Tremor
| Device Type ID | 3865 |
| Device Name | Stimulator, Electrical, Implanted, For Essential Tremor |
| Physical State | System Components Include Implantable Pulse Generator, Leads, Extensions, Patient Programmer, And Charger |
| Technical Method | Implantable Pulse Generator Will Produce Electrical Pulses Which Will Stimulate Deep Brain Structures Through Electrodes On Leads. |
| Target Area | Deep Brain Structures |
| Review Panel | Neurology |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Neurological And Physical Medicine Devices (DNPMD) Neurostimulation Devices Neurology Branch (NSDN) |
| Submission Type | PMA |
| FDA Device Classification | Class 3 Medical Device |
| Product Code | PJS |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 3865 |
| Device | Stimulator, Electrical, Implanted, For Essential Tremor |
| Product Code | PJS |
| FDA Device Classification | Class 3 Medical Device |
| Device Problems | |
|---|---|
Appropriate Term/Code Not Available | 1 |
| Total Device Problems | 1 |