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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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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 NameNEUROCYBERNETIC PROSTHESIS (NCP) SYSTEM
Classification Namestimulator, autonomic nerve, implanted for epilepsy
ApplicantCYBERONICS, INC.
PMA NumberP970003
Supplement NumberS011
Date Received10/01/1998
Decision Date10/16/1998
Product Code
LYJ[ Registered Establishments with LYJ ]
Advisory Committee Neurology
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product 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.
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