|Trade Name||PARADYM MODEL 8750 CRT-D WITH SMARTVIEW 2.16 UG2 PROGRAMMER SOFTWARE|
|Classification Name||defibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d)|
|Applicant||ELA MEDICAL, INC.|
|Supplement Type||30-day notice|
|Supplement Reason|| change design/components/specifications - component|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for the paradym model 8750 crt-d with smartview 2. 16 ug2 programmer software. The device is indicated for ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life threatening arrhythmias. The device is also indicated for the reduction of heart failure symptoms in medically optimized nyha functional class iii and iv patients with left ventricular ejection fraction of 35% or less, and a qrs duration of 150 ms or longer.