|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 Name||VNS THERAPY PERENNIAFLEX|
|Classification Name||stimulator, autonomic nerve, implanted for epilepsy|
|Supplement Type||real-time process|
|Supplement Reason|| change design/components/specifications - component|
|Expedited Review Granted?|| 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.