Device |
stimulator, electrical, implanted, for essential tremor |
Definition |
Deep Brain Stimulation for the treatment of 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 |
Product Code | PJS |
Premarket Review |
Office of Neurological and Physical Medicine Devices
(OHT5)
Neuromodulation and Physical Medicine Devices
(DHT5B)
|
Submission Type |
PMA
|
Device Class |
3
|
Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
GMP Exempt? |
No
|
Summary Malfunction Reporting |
Ineligible |
Implanted Device? |
Yes
|
Life-Sustain/Support Device? |
No
|
Third Party Review |
Not Third Party Eligible |
|
|