BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Automated Insulin Dosing Device System, Single Hormonal Control

    PMA: P160017 · Supplement: S122 · Decision Aug 20, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

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    Basic Information

    Device Name
    Automated Insulin Dosing Device System, Single Hormonal Control
    Trade Name
    MiniMed 770G System
    PMA Number
    P160017
    Supplement Number
    S122
    Device Class
    FDA Class 3
    Product Code
    OZP
    Generic Name
    Automated insulin dosing device system, single hormonal control
    Medical Specialty
    Unknown
    Advisory Committee
    Clinical Chemistry
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    August 20, 2025
    Date Received
    February 21, 2025
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Labeling Change - PAS
    Expedited Review
    N

    Advisory Committee Statement

    Approval for modified labeling for the MiniMed 770G System to include descriptive results of the post-approval study previously mandated under the approval order of P160017.

    Classifications

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

    Product Code Device Name
    OZP Automated Insulin Dosing Device System, Single Hormonal Control