EnteroMedics completes VBLOC therapy pre-PMA meeting with FDA

theflyonthewall.com

EnteroMedics announced that the company completed a pre-PMA application meeting with the FDA on May 15 regarding the Maestro Rechargeable System's VBLOC vagal blocking therapy as a treatment for obesity. In the meeting, the FDA indicated that, subject to acceptance of the application and validation and detailed review of the submitted data by the FDA, the company can anticipate presenting the PMA before a future FDA Advisory Committee panel. The company expects to submit a PMA for the Maestro Rechargeable System, based on the ReCharge Pivotal Trial, in the second quarter of 2013.

View Comments (0)