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 | |
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Appropriate Term/Code Not Available | 1 |
Total Device Problems | 1 |