BSD Medical Announces Conclusion of FDA Pre-approval Audit for BSD-2000 PMA Submission.SALT LAKE CITY -- BSD (Berkeley Software Distribution) The software distribution facility of the Computer Systems Research Group (CSRG) of the University of California at Berkeley. Medical Corp. (AMEX AMEX See: American Stock Exchange : BSM) today announced the completion of the Food and Drug Administration's (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) pre-approval audit for the PMA PMA (papillary-marginal-attached), n a system of epidemiologic scoring of periodontal disease devised by Schour and Massler in which the symbols denote the areas involved in gingival inflammation. PMA Progressive muscular atrophy submission of the company's BSD-2000 hyperthermia hyperthermia /hy·per·ther·mia/ (-ther´me-ah) hyperpyrexia; greatly increased body temperature.hyperther´malhyperther´mic malignant hyperthermia system, along with the completion of a routine Quality System (QA)/Good Manufacturing Practices (GMP) inspection. FDA did not provide any written inspectional deficiencies (Form 483) at the conclusion of the on-site inspection. The completion of the preapproval FDA inspection is a significant milestone in the PMA approval process for a medical device. The FDA's review of the company's PMA submission is ongoing. FDA conducts a pre-approval inspection following submission of a PMA to verify that the company's design and manufacturing processes meet the Quality System (QS) regulations. This process involved a 5-day on-site inspection by an FDA auditor. The inspection was concluded on August 21, 2007. BSD Medical Corp. is the leading developer of systems used to deliver hyperthermia therapy for the treatment of cancer. For further information about BSD Medical visit the company's website at www.BSDMedical.com. Statements contained in this press release that are not historical facts are forward-looking statements, as defined in the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and of 1995. All forward-looking statements are subject to risks and uncertainties detailed in the Company's filings with the Securities and Exchange Commission. |
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