|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|| change design/components/specifications - software|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for the addition of a software accessory/tool referred to as the ¿generator field upgrader¿ (gfu). The gfu is designed to be used to upgrade software in the demipulse, model 103 and demipulse duo, model 104 pulse generators to either enhance pre-existing features or to resolve software anomalies.