Brachytherapy and hyperthermia therapy developer BSD Medical of Salt Lake City met a milestone in its premarket approval (PMA) application process with the U.S. Food and Drug Administration (FDA).
The company reported that the FDA has completed its preapproval audit for BSD's PMA submission for its BSD-2000 hyperthermia system. The FDA also completed a quality system/good manufacturing practices check, a five-day onsite inspection by an FDA auditor.
By AuntMinnie.com staff writers
August 23, 2007
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