|Trade Name||VIGILA AND VOLTA AND PASSIVE FIXATION BIPOLAR STEROID ELUTING ICD LEADS|
|Classification Name||permanent defibrillator electrodes|
|Generic Name||permanent defibrillator electrodes|
|Supplement Type||normal 180 day track|
|Supplement Reason|| change design/components/specifications/material|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for the following: 1) addition of trade names vigila and volta for the linox and linox smart defibrillation leads; 2) change to indications for use statement to clarify that the vigila and volta leads maybe used with any manufacturers' icds; and 3) accessory kits for use with the vigila and volta leads.