BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Neuromodulator For Obesity

    PMA: P130019 · Supplement: S005 · Decision Apr 24, 2015
    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
    S005
    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
    April 24, 2015
    Date Received
    March 24, 2015
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A FORMULATION CHANGE TO YOUR SILICONE MATERIAL USED IN THE TRANSMIT COILS FOR THE MAESTRO® RECHARGEABLE SYSTEM.

    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