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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
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 NumberS087
Date Received08/17/2007
Decision Date09/04/2007
Product Code
LYJ[ Registered Establishments with LYJ ]
Advisory Committee Neurology
Supplement Type30-day notice
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
ADDITION OF A NEW MODEL PACKAGING SYSTEM FOR THE DEVICE.
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