|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.|
|Classification Name||ablation system, high intensity focused ultrasound (hifu), mr-guided|
|Generic Name||ablation system, high intensity focused ultrasound (hifu), mr-guided|
|Supplement Type||normal 180 day track|
|Supplement Reason|| change design/components/specifications/material|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for modification of the exablate platform 1) so that the same platform can be used with multiple cradles; and 2) to enable the cradle that has the capability to move the transducer in the anterior and posterior directions be used in the locked position forcommercial uterine fibroid treatment.