BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Neuromodulator For Obesity

    PMA: P130019 · Supplement: S009 · Decision Jun 27, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3

    Basic Information

    Device Name
    Neuromodulator For Obesity
    Trade Name
    MAESTRO RECHARGEABLE SYSTEM
    PMA Number
    P130019
    Supplement Number
    S009
    Device Class
    FDA Class 3
    Product Code
    PIM
    Generic Name
    neuromodulator for obesity
    Medical Specialty
    Unknown
    Advisory Committee
    Gastroenterology, Urology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    June 27, 2016
    Date Received
    June 7, 2016
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Postapproval Study Protocol
    Expedited Review
    N

    Advisory Committee Statement

    Approval of an amended protocol for the ODE Lead PMA Post-Approval Study.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    PIM Neuromodulator For Obesity