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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
Generic NameStimulator, autonomic nerve, implanted for epilepsy
ApplicantLivaNova USA, Inc.
100 Cyberonics Blvd.
Houston, TX 77058
PMA NumberP970003
Supplement NumberS095
Date Received11/21/2007
Decision Date12/19/2007
Product Code LYJ 
Advisory Committee Neurology
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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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