|Trade Name||ACTIVA TREMOR CONTROL THERAPY SYSTEM|
|Classification Name||stimulator, electrical, implanted, for parkinsonian tremor|
|Generic Name||implantable electrical thalmic stimulation system - deep brain stimulation|
|Supplement Type|| Special Supplement|
|Supplement Reason|| process change: manufacturing|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for the addition of an additional quality contorol process step to verify that neurostimulators are manufactured to their specification, e. G. , the neurostimulator has the specified insulation between the battery and the internal surface of the titanium case (shield).