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Weight loss: FDA asks for more info on EnteroMedics’ Maestro implant

September 24, 2013 By Mass Device

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.

EnteroMedics is on track, forsees FDA decision early next year

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.”

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  • Home
  • Medical Device Business
    • Mergers & Acquisitions
    • Financial
    • Regulatory
  • Applications
    • Cardiovascular
    • Devices
    • Imaging
    • Implantables
    • Medical Equipment
    • Orthopedic
    • Surgical
  • Technologies
    • Supplies and Components Index
    • Contract Manufacturing
    • Components
    • Electronics
    • Extrusions
    • Materials
    • Motion Control
    • Prototyping
    • Pumps
    • Tubing
  • MedTech Resources
    • Medtech Events in 2025
    • The 2024 Medtech Big 100
    • Medical Device Handbook
    • MedTech 100 Index
    • Subscribe to Print Magazine
    • DeviceTalks
    • Digital Editions
    • eBooks
    • Manufacturer Search
    • Podcasts
    • Print Subscription
    • Webinars / Digital Events
    • Whitepapers
    • Voices
    • Video
  • 2025 Leadership
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  • Women in Medtech
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