|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 SYSTEM|
|Classification Name||stimulator, autonomic nerve, implanted for epilepsy|
|Supplement Type|| Special Supplement|
|Supplement Reason|| labeling change - other|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for the addition of detailed information contained in the approved test to the figures provided in the labeling to provide further clarification concerning the proper lead implant technique. Additionally, further details were provided to stress the importance of proper strain relief placement (i. E. Proper tie-down location and strain relief bend).