|Trade Name||MODEL 2725 VENTAK PRIZM DIAGNOSTIC/RESTORATION TOOL|
|Classification Name||implantable pulse generator, pacemaker (non-crt)|
|Generic Name||implantable pulse generator, pacemaker (non-crt)|
|Supplement Type||real-time process|
|Supplement Reason|| change design/components/specifications/material|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for model 2725 ventak(r) prizm(tm) diagnostic/restoration tool version 1. 5. The device is indicated to diagnose and restore to factory normal settings ventak prizm/prizm he devices that have been affected by a specific memory interation that results in safety mode.