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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 PULSE 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 NumberS142
Date Received12/02/2011
Decision Date12/23/2011
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 
TWO REVISIONS TO THE SOFTWARE USED IN THE AUTOMATED FUNCTIONAL TEST SYSTEM (AFT) FOR THE VNS THERAPY SYSTEM PULSE GENERATORS.
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