|Trade Name||LUMOS VR-T AND LUMOS DR-T IMPLANTABLE CARDIOVERTER DEFIBRILLATORS WITH 502.U ICS PROGRAMMER SOFTWARE, A-K00.4.U EPR/...|
|Classification Name||defibrillator, implantable, dual-chamber|
|Generic Name||implantable cv defibrillator/pacemaker programmer/icd monitoring system|
|Supplement Type||real-time process|
|Supplement Reason|| change design/components/specifications - other|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval to implement intracardiac electrogram (iegm) snapshots of tachycardia events into home monitoring transmissions. In order to accomplish this, you have requested the approval of the lumos family of icds programmer software upgrades, and an upgrade to the currently marketed home monitoring service center.