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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.
 
DeviceNEUROCYBERNETIC PROSTHESIS (NCP) SYSTEM
Classification Namestimulator, autonomic nerve, implanted for epilepsy
Generic Namestimulator, autonomic nerve, implanted for epilepsy
Applicant
Cyberonics, Inc.
100 cyberonics blvd.
houston, TX 77058-2017
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 - manufacturer/sterilizer/packager/supplier
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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