BSD Medical Corporation

BSD Medical Receives Letter from FDA on BSD-2000 Submission

Published in Medical Letter on the CDC and FDA, January 27th, 2008

BSD Medical Corporation (AMEX:BSM) announced that it received a letter from the Food and Drug Administration (FDA) regarding its Premarket (PMA) submission for the BSD-2000 Hyperthermia System. The letter from the FDA provides guidance as to amendments needed to make the PMA approvable. The company is currently preparing its response to the amendments proposed by the FDA.

On July 31, 2007, BSD provided detailed answers to a significant number of questions from the FDA following its initial review of the BSD-2000 PMA submission. This letter is the only response to the submission that BSD has received from the FDA since it provided answers to the FDA's questions in...

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Source: Medical Letter on the CDC and FDA (2008-01-27)

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