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News Breaks | | | | March 7, 2013 | | 08:40 EDT |  | EDAP | EDAP says FDA gives positive administrative acceptance review for Ablatherm PMA
EDAP TMS SA announced that the U.S. Food and Drug Administration has provided a positive administrative acceptance review notification for the Company's Pre-Market Approval, or PMA, application for its Ablatherm Integrated Imaging High Intensity Focused Ultrasound device for treatment of low risk, localized prostate cancer. The FDA conducted an administrative acceptance review of EDAP's PMA application and found it to contain all of the necessary elements and information needed to proceed with filing review. Based on the FDA PMA Review Process, the administrative acceptance review is the first step in the multi-step process and the next step is the filing review. Both of these reviews access the completeness of the application and not the clinical outcomes of the study, which begins after a positive filing review, the company said. | |
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News For EDAP From The Last 14 Days Check below for free stories on EDAP the last two weeks. |
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| May 24, 2013 | | 10:34 EDT | | EDAP | Sabby reports 5.79% passive stake in EDAP TMS
 Subscribe for More Information | | | May 20, 2013 | | 09:28 EDT | | EDAP | EDAP's Ablatherm-HIFU demonstrates long-term efficacy
Subscribe for More Information | | | May 16, 2013 | | 07:35 EDT |  | EDAP | EDAP TMS reports Q1 EPS (27c), may not compare to one estimate (5c)
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