|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 GENERATOR (DEMIPULSE AND DEMIPULSE DUO), VNS THERAPY GENERATOR (ASPIREHC)|
|Classification Name||stimulator, autonomic nerve, implanted for epilepsy|
|Supplement Type||real-time process|
|Supplement Reason|| change design/components/specifications - specifications|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for a change to the printed circuit board assembly manufacturing design requirement for voltage measurement accuracy and tolerance associated with its electrical testing.