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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 NumberS140
Date Received10/21/2011
Decision Date12/20/2011
Product Codes LYJ MUZ 
Advisory Committee Neurology
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR : 1) REMOVAL OF THE CR10 AND CR11 TVS DIODES FROM THE PCBA DESIGN; AND 2) A CHANGE TO THE PRINTED CIRCUIT BOARD (PCB) SPECIFICATION TO ACCEPT VIAS (VERTICAL ELECTRICAL CONNECTIONS BETWEEN DIFFERENT LAYERS OF CONDUCTORS ON A PCB) FILLED WITH EPOXY FROM THE PCB VENDOR, WHICH IS CURRENTLY ALLOWED FOR THE MODEL 103/104 PULSE GENERATORS.
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