EDAP TMS SA, today announced that the U.S. Food and Drug Administration (FDA) concluded its routine inspection of EDAP's manufacturing site with no findings nor issuance of Form 483 observations. Marc Oczachowski, EDAP's Chief Executive Officer, commented, "This is another important step in the FDA PMA process for our Ablatherm-HIFU technology. It confirms and validates EDAP's ability to comply with high engineering, manufacturing and quality standards. In parallel, our team remains fully focused on preparing for the July 30, 2014 advisory committee meeting."
News & Media
Jun 27, 2014
EDAP Completes FDA Inspection of Manufacturing Site
FDA Inspector Reported no Findings From the Scheduled Facility Audit.