|Trade Name||ACTIVA TREMOR CONTROL THERAPY SYSTEM|
|Classification Name||stimulator, electrical, implanted, for parkinsonian tremor|
|Generic Name||stimulator, electrical, implanted, for parkinsonian tremor|
|Supplement Type||special (immediate track)|
|Supplement Reason|| process change - manufacturer/sterilizer/packager/supplier|
|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).