|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||NEUROCYBERNETIC PROTHESIS SYSTEM|
|Classification Name||stimulator, autonomic nerve, implanted for epilepsy|
|Supplement Type||real-time process|
|Supplement Reason|| change design/components/specifications - other|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for ncp(r) model 100c pulse generator with modifications to the microcontroller and battery. The device, as modified, will be marketed under the trade name ncp(r) model 100c pulse generator ans is indicated for use as an adjunctive therapy in reducing the frequency of seizures in adults and adolescents over 12 years of age with pertial onset seizures, which are refractory to anti-epileptic medications.