|Trade Name||MRDTRONIC 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|| labeling change - indications/instructions/shelf life/tradename|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for corrections to an educational brochure which contains instructions for routing and implantation of the lead to extension connection and the addition of a new warning label.