|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/NCP/VNS PULSE GENERATORS|
|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 a labeling modification regarding the internal clock reset in the model 100, 101, 102 and 102r implanted pulse generators (ipgs).