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ExAblate® 2000 System

Internet URL

http://www.fda.gov/cdrh/mda/docs/p040003.html  

Sponsoring Agency

Center for Devices and Radiological Health, U.S. Food and Drug Administration

Description

ExAblate® 2000 is a new medical device that uses magnetic resonance image guided focused ultrasound to target and destroy uterine fibroids, non-cancerous masses located in the uterus. The device is intended to treat women who have completed child bearing or do not intend to become pregnant. ExAblate® 2000 is non-invasive surgery. It spares the uterus and is an alternative to myomectomy, hysterectomy, watchful waiting, hormone therapy, or uterine fibroid embolization. Treatment typically lasts about three hours.

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Review Date

4/25/2007