FDAnews Device Daily Bulletin

BSD MEDICAL CORP.'S PMAA FOR THE BSD-2000 ACCEPTED FOR FILING BY FDA

May 24, 2006
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BSD Medical Corp. announced May 22 its Pre-market Approval Application (PMAA) for the BSD-2000 cancer treatment system has been accepted for filing and review by the U.S. Food and Drug Administration (FDA). Acceptance for filing indicates that the FDA considers the PMAA (consisting of 7,243 pages contained in 24 volumes) to be complete and warrants full review of the data needed to assess the safety and efficacy of the BSD-2000. FDA acceptance for filing of the PMAA is an important step in the approval process in the United States, but acceptance for filing by the FDA does not mean that the PMAA has been or will be approved. Acceptance of the PMAA for filing by the FDA marks an important milestone for the company. BSD Medical (http://www.bsdmc.com/press.html?id=183)