|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 PULSE GENERATOR, LEAD AND PATIENT KIT|
|Classification Name||stimulator, autonomic nerve, implanted for epilepsy|
|Supplement Type||real-time process|
|Supplement Reason|| labeling change - instructions|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for labeling harmonization and modularization for physician, pulse generator, lead and patient kit labeling.