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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 NumberS089
Date Received09/10/2007
Decision Date10/11/2007
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 THE ADDITION OF INSTRUCTIONS TO THE TROUBLESHOOTING SECTION IN THE MODEL 250 PROGRAMMING SOFTWARE PHYSICIAN?S MANUAL V.7.1 AND MINOR CORRESPONDING CHANGES TO THE HANDHELD COMPUTER CONNECTION INSTRUCTIONS (HP JORNADA, DELL AXIM X5 AND X50).
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