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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 (depression)
Generic Namestimulator, autonomic nerve, implanted (depression)
Applicant
LivaNova USA, Inc.
100 cyberonics blvd.
houston, TX 77058
PMA NumberP970003
Supplement NumberS154
Date Received11/06/2012
Decision Date02/01/2013
Product Code
MUZ[ Registered Establishments with MUZ ]
Advisory Committee Neurology
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR AN UPGRADE OF THE PROGRAMMING SOFTWARE TO VERSION 10.0, A NEW PROGRAMMING COMPUTER AND CORRESPONDING ADAPTER CABLE, AND REVISION OF THE HIGH IMPEDANCE THRESHOLD.
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