|Trade Name||VENTAK AV ICD|
|Classification Name||implantable pulse generator, pacemaker (non-crt)|
|Generic Name||cardiac resynchronization therapy defibrillator (crt-d) system|
|Supplement Type||real-time process|
|Supplement Reason|| change design/components/specifications - component|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for an updated header configuration for the confient and livian device families to include changed setscrews, seal plugs, and left ventricular ring lead wire routing (livian only) as well as the addition of a new model torque wrench.