|Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.|
|Trade Name||VNS THERAPY SYSTEM|
|Classification Name||stimulator, autonomic nerve, implanted for epilepsy|
|Supplement Type|| Special Supplement|
|Supplement Reason|| labeling change - instructions|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for the addition of instructions to the troubleshooting section in the model 250 programming software physician?s manual v. 7. 1 and minor corresponding changes to the handheld computer connection instructions (hp jornada, dell axim x5 and x50).