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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.
 
DeviceVNS THERAPY 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 NumberS140
Date Received10/21/2011
Decision Date12/20/2011
Product Code
LYJ[ Registered Establishments with LYJ ]
Advisory Committee Neurology
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for : 1) removal of the cr10 and cr11 tvs diodes from the pcba design; and 2) a change to the printed circuit board (pcb) specification to accept vias (vertical electrical connections between different layers of conductors on a pcb) filled with epoxy from the pcb vendor, which is currently allowed for the model 103/104 pulse generators.
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