|Trade Name||ACTIVA TREMOR CONTROL 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 a change to the manufacturing process to include an additional method for monitoring ethylene gas concentrations during the sterilization process.