The Sonablate® 500 is approved for medical
use in México, Canada, UK, China, Australia, Japan, Costa
Rica, South Africa and the Caribbean. The Sonablate® 500 is
approved only for investigational use in the United States. Any
discussion of treatment, clinical data interpretations or conclusions,
instructions for use, and visual depictions of use are specific
to one or more countries where the Sonablate® 500 is approved
for use in the treatment of Prostate cancer and other indications.
Sonablate®
is a Registered Trademark of Focus Surgery, Inc.(www.focus-surgery.com)
of Indianapolis. 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. Sonablate®
HIFU is only available in countries where the device has already
been approved. |
