|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||real-time process|
|Supplement Reason|| design change - minor|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for a change from adding a strain relief grommet to the serial data cable of the model 201 programming wand during final assembly to molding an improved strain relief onto the serial data cable during its manufacture and changes to the tie-down used in the model 302 lead, the model 303 lead, and the model 502 accessory pack.