|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||ILESTO ICD'S AND CRT-D'S|
|Classification Name||defibrillator, implantable, dual-chamber|
|Supplement Type||normal 180 day track|
|Supplement Reason|| change design/components/specifications - component|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for mri-conditional labeling for the entovis sr / sr-t / dr / dr-t pacemakers, and the supporting programmer software version psw 1307. U. When an entovis pacemaker is used in conjunction with setrox s 53/60 or safio 53/60 pacemaker leads it shall be identified as the entovis promri system.