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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 NumberS074
Date Received10/10/2006
Decision Date10/31/2006
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 THE ADDITION OF A PRECAUTION TO THE MODEL 250 PROGRAMMING SOFTWARE PHYSICIAN?S MANUAL V.6.1 AND MODEL 250 PROGRAMMING SOFTWARE PHYSICIAN?S MANUAL V.7.0 IN THREE DIFFERENT PLACES IN EACH OF THE RESPECTIVE MANUALS.
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