|Trade Name||EXABLATE 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||special (immediate track)|
|Supplement Reason|| labeling change - indications/instructions/shelf life/tradename|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for labeling changes including: 1) deletion of the comment (outcomes of 10 pregnancies are pending as of august 2008, and outcome of one pregnancy is unknown. ) and addition of deep vein thrombosis under the section entitled other adverse events.