FDANews
The QMN Weekly Bulletin

BSD Medical Announces Conclusion of FDA Pre-approval Audit for BSD-2000 PMA Submission

Aug. 24, 2007

BSD Medical announced the completion of the Food and Drug Administration’s (FDA) pre-approval audit for the PMA submission of the company’s BSD-2000 hyperthermia system, along with the completion of a routine Quality System (QS)/Good Manufacturing Practices (GMP) inspection. FDA did not provide any written inspectional deficiencies (Form 483) at the conclusion of the on-site inspection.
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