|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 DEMIPULSE & DEMIPULSE DUO GENERATORS|
|Classification Name||stimulator, autonomic nerve, implanted for epilepsy|
|Supplement Type||real-time process|
|Supplement Reason|| change design/components/specifications - software|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for two changes to he pulse generator software to eliminate a rare timing condition that may cause the software watchdog to, at the end of a magnet-initiated burst, report an error even though no such error occurred.