EnteroMedics Inc.
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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