|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 changes consisting of adding ?seroma? as an additional possible adverse event in the epilepsy and depression information modules and adding a note describing possible risks with replacing a larger pulse generator with a smaller one in the revision/ replacement/ removal module.