EnteroMedics Says On Track for FDA Approval of Maestro PMA During 1H14, Says Has Received Formal Response from FDA
EnteroMedics Inc. (NASDAQ: ETRM), the developer of medical devices using neuroblocking technology to treat obesity, metabolic diseases and other gastrointestinal disorders, today announced that the Company has received a formal response, a standard component of the PMA process, from the Food and Drug Administration (FDA) with regard to its Premarket Approval Application (PMA) for approval of the Maestro Rechargeable System as a treatment for obesity. The response contains follow-up questions related to the application pertaining primarily to device testing and clinical data, including training programs for users and a post approval study. The Company anticipates responding to the FDA's questions within the coming weeks.
"We are very encouraged by the responsiveness of the FDA and are confident in our ability to address their questions in a timely manner," said Mark B. Knudson, Ph.D., EnteroMedics' President and Chief Executive Officer. "We will continue to work closely with the FDA throughout this process. We believe that the Company continues on track for a panel in late Q4 2013/Q1 2014 with approval decision in the first half of 2014."
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