|Trade Name||NEUROCYBERNETIC PROSTHESIS (NCP) SYSTEM|
|Classification Name||stimulator, autonomic nerve, implanted for epilepsy|
|Generic Name||stimulator, autonomic nerve, implanted for epilepsy|
|Supplement Type||special (immediate track)|
|Supplement Reason|| labeling change - indications/instructions/shelf life/tradename|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for labeling changes being made to the model 100 ncp pulse generator physician's manual, the model 300 ncp bipolar lead physician's manual, and the patient's manual for the ncp system.