|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||normal 180 day track|
|Supplement Reason|| location change: sterilizer|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for an alternative sterilization process (hydrogen peroxide gas plasma using the sterrad 200 gmp sterilizer) for the model 401 tunneler and approval of a protocol for b1 incubation reduction and shelf life study, as well as a new sterilization facility (cyberonics, inc. , houston, texas).