|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||30-day notice|
|Supplement Reason|| process change: manufacturing|
|Expedited Review Granted?|| No|
|Approval Order Statement |
The 30-day notice requested that a welding process be added to the firms' internal manufacturing capabilities. This process is equivalent to the welding process already performed by cyberonics' subcontractors. The process is being brougth in-house in order to simplify the manufacturing process, improve control of product flow, and improve product availability.