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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) PROGRAMMING WAND
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 NumberS102
Date Received10/01/2008
Decision Date11/12/2008
Product Code
LYJ[ Registered Establishments with LYJ ]
Advisory Committee Neurology
Supplement Typespecial (immediate track)
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for labeling changes that include the addition of confirmatory testing information, strengthening of warnings, and formatting revisions.
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