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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