Weight-loss devices maker EnteroMedics says it’s still on track with its premarket approval application, expecting a decision early next year despite the FDA’s request for more information.
Minnesota medical device maker EnteroMedics (NSDQ:ETRM) appeared unfazed by the FDA’s response to the company’s premarket approval application, anticipating no slowdown in the regulatory process for its landmark Maestro weight-loss implant.
“We are very encouraged by the responsiveness of the FDA and are confident in our ability to address their questions in a timely manner,” president & CEO Mark Knudson said in prepared remarks. “We believe that the company continues on track for a panel in late Q4 2013/Q1 2014 with approval decision in the 1st half of 2014.”
