|Trade Name||VITALITY ICD|
|Classification Name||implantable pulse generator, pacemaker (non-crt)|
|Generic Name||implantable pulse generator, pacemaker (non-crt)|
|Supplement Type||30-day notice|
|Supplement Reason|| process change - manufacturer/sterilizer/packager/supplier|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Change in the manufacturing process to expand the guidant clonmel, ireland plant by adding hybrid fabrication capability to the vitality family of devices.