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The Sonablate® 500 is approved only for investigational use in the United States.
It is approved for commercial use only in certain foreign countries. Any discussion of
clinical data interpretations or conclusions, instructions for use,
and visual depictions of use are specific to one or more foreign
countries where the SB-500 is approved for use.
Sonablate® is a Registered Trademark of Focus Surgery, Inc. of
Indianapolis, IN. The Sonablate® 500 is only approved for
investigational use in clinical trials by the United Stated Food and
Drug Administration. Focus Surgery, Inc. is the sponsor of the
clinical studies.
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