News | June 29, 2008

EnteroMedics Receives ISO 13485 Certification for Surgical System

June 30, 2008 - EnteroMedics Inc., the developer of medical devices using neuroblocking technology to treat obesity and other gastrointestinal disorders, said today that it has received ISO 13485:2003 certification from KEMA Quality B.V. for the design, manufacture and distribution of surgical implants and associated accessories for nervous impulse modulation for the purpose of regulating gastrointestinal and metabolic disorders.

EnteroMedics is in testing of VBLOC vagal blocking therapy, delivered via the Maestro System, for the treatment of obesity.

ISO 13485 is a regulatory standard for the international medical industry that ensures manufacturer conformity with certain quality controls in the development of safe and effective medical devices. ISO 13485 certification is also a regulatory requirement for medical devices distributed in a number of international markets, and an important step toward CE mark approval in the European Union.

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