|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 to bring in-house a seam welding process equivalent to processes performed by subcontractors. The welding process involves welding the can bottom half of the pulse generator to a can lid.