|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||real-time process|
|Supplement Reason|| labeling change - minor|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for the following changes to the labeling harmonization and modularization for physician pulse generator and lead labeling: 1) the addition of a manual entitled, ?revision/replacement/removal procedure manual?. 2) the incorporation of the physician?s manual for the model 303 lead into the harmonized labeling which includes the addition of the modular physician?s manual entitled, ?technical information ? vns therapy perennia model 303 lead?. 3) revisions to the ?implantation procedure? module.