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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 PERENNIAFLEX
Generic NameStimulator, autonomic nerve, implanted for epilepsy
ApplicantLivaNova USA, Inc.
100 Cyberonics Blvd.
Houston, TX 77058
PMA NumberP970003
Supplement NumberS100
Date Received07/24/2008
Decision Date12/19/2008
Product Code LYJ 
Advisory Committee Neurology
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR THE FOLLOWING MINOR MODIFICATIONS TO THE APPROVEDMODEL 303 STIMULATION LEAD (THE NEW MODEL TO BE REFERRED TO AS "304"):1) CHANGING THE COIL MATERIAL TO ONE WITH A LOWER TITANIUM TOLERANCE (< 0.01%) TO IMPROVEFATIGUE RESISTANCE;2) CHANGING THE INSULATING MATERIAL TO ONE THAT IS SIMILAR, BUT WITH IMPROVED FATIGUE ANDABRASION RESISTANCE;3) ADDING A CONTROLLED FILLET TO THE ELECTRODE BIFURCATION TO IMPROVE FATIGUE RESISTANCE, AND4) ADDING AN INTERMEDIATE ELECTRODE SIZE (2.5 MM) THAT ALSO OFFERS NERVE COVERAGE >360 DEGREES.
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