|Trade Name||NEUROCYBERNETIC PROTHESIS (NCP) SYSTEM|
|Classification Name||stimulator, autonomic nerve, implanted for epilepsy|
|Generic Name||stimulator, autonomic nerve, implanted for epilepsy|
|Supplement Type||real-time process|
|Supplement Reason|| change design/components/specifications/material|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for the neurocybernetic prothesis (ncp) system model 102r generator, human factors improvements to the model 102 generator and labeling changes to the model 302 lead which are indicated for use as an adjunctive therapy in reducing the frequency of seizures that are refractory to antiepileptic medications.