|Trade Name||NEUROCYBERNETIC PROSTHESIS (NCP) SYSTEM|
|Classification Name||stimulator, autonomic nerve, implanted for epilepsy|
|Generic Name||stimulator, autonomic nerve, implanted for epilepsy|
|Supplement Type||30-day notice|
|Supplement Reason|| process change - manufacturer/sterilizer/packager/supplier|
|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.