|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 PROSTHESIS (NCP) SYSTEM|
|Classification Name||stimulator, autonomic nerve, implanted for epilepsy|
|Supplement Type|| Special Supplement|
|Supplement Reason|| labeling change - instructions|
|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.