|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||real-time process|
|Supplement Reason|| design change - minor|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for : 1) removal of the cr10 and cr11 tvs diodes from the pcba design; and 2) a change to the printed circuit board (pcb) specification to accept vias (vertical electrical connections between different layers of conductors on a pcb) filled with epoxy from the pcb vendor, which is currently allowed for the model 103/104 pulse generators.