|Trade Name||VENTAK AND CONTAK CD FAMILIES OF ICDS|
|Classification Name||implantable pulse generator, pacemaker (non-crt)|
|Generic Name||implantable pulse generator, pacemaker (non-crt)|
|Supplement Type||special (immediate track)|
|Supplement Reason|| labeling change - indications/instructions/shelf life/tradename|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for modifications to the labeling for the ventak (p960040) and contak cd (p010012) families of implantable defibrillators to include information regarding behavior of these devices attributable to the svo (silver vanadium oxide) used to power them. Specifically, an update to the system guide to include language to identify as normal an increased charged time in midlife due to the inherent characteristics of the svo batteries used.