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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 NumberS095
Date Received11/21/2007
Decision Date12/19/2007
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 CHANGES CONSISTING OF ADDING ?SEROMA? AS AN ADDITIONAL POSSIBLE ADVERSE EVENT IN THE EPILEPSY AND DEPRESSION INFORMATION MODULES AND ADDING A NOTE DESCRIBING POSSIBLE RISKS WITH REPLACING A LARGER PULSE GENERATOR WITH A SMALLER ONE IN THE REVISION/ REPLACEMENT/ REMOVAL MODULE.
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