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Misonix Sonablate PMA Submission For BPH Expected In September

This article was originally published in The Gray Sheet

Executive Summary

Misonix is looking toward a late September premarket approval application filing date for the Sonablate 200 high intensity focused ultrasound (HIFU) device in treating benign prostatic hyperplasia. Commercial release of the product in the U.S. is expected sometime in 2001.
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