|Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.|
|Trade Name||LUMAX 540 VR-T DX ICD|
|Classification Name||defibrillator, implantable, dual-chamber|
|Supplement Type||real-time process|
|Supplement Reason|| change design/components/specifications - other|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for introduction of the lumax 540 vr-t dx implantable cardioverter defibrillator (icd), a single lead icd system used in conjunction with the currently approved kainox a+ icd lead. The device, as modified, will be marketed under the trade name lumax 540 vr-t dx icd and is indicated for providing ventricular antitachycardia pacing and ventricular defibrillation, for automated treatment of life threatening ventricular arrhythmias.