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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 GENERATORS
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 NumberS147
Date Received03/14/2012
Decision Date04/13/2012
Product Code
MUZ[ Registered Establishments with MUZ ]
Advisory Committee Neurology
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
INTRODUCTION OF AN ADDITIONAL RECEIVING INSPECTION FOR THE TORQUE WRENCH THAT IS PACKAGED WITH THE VNS THERAPY SYSTEM GENERATORS.
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