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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameVNS THERAPY PERENNIAFLEX
Classification Namestimulator, autonomic nerve, implanted for epilepsy
ApplicantCYBERONICS, INC.
PMA NumberP970003
Supplement NumberS100
Date Received07/24/2008
Decision Date12/19/2008
Product Code
LYJ[ Registered Establishments with LYJ ]
Advisory Committee Neurology
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the following minor modifications to the approved model 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 improve fatigue resistance; 2) changing the insulating material to one that is similar, but with improved fatigue and abrasion resistance; 3) adding a controlled fillet to the electrode bifurcation to improve fatigue resistance, and 4) adding an intermediate electrode size (2. 5 mm) that also offers nerve coverage >360 degrees.
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