News | News By Subject | News by Disease News By Date | Search News
Get Our FREE
Industry eNewsletter
email:    
   

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


8/23/2007 7:31:59 AM

SALT LAKE CITY--(BUSINESS WIRE)--BSD Medical Corp. (AMEX: BSM) today 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 (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.

Read at BioSpace.com

comments powered by Disqus
   

ADD TO DEL.ICIO.US    ADD TO DIGG    ADD TO FURL    ADD TO STUMBLEUPON    ADD TO TECHNORATI FAVORITES