|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) (ASPIREHC)|
|Classification Name||stimulator, autonomic nerve, implanted for epilepsy|
|Supplement Type||real-time process|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for a change to the transmit to receive refractory time which is a specification of the application specific integrated circuit (asic) used in model 103/104/105 vns generators and the implementation of a screening test to be performed at the vendor (on semiconductor).