BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Sensor, Glucose, Implanted, Non-Adjunctive Use

    PMA: P160048 · Supplement: S012 · Decision Nov 25, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7

    Basic Information

    Device Name
    Sensor, Glucose, Implanted, Non-Adjunctive Use
    Trade Name
    EVERSENSE CONTINUOUS GLUCOSE MONITORING SYSTEM
    PMA Number
    P160048
    Supplement Number
    S012
    Device Class
    FDA Class 3
    Product Code
    QHJ
    Generic Name
    Sensor, glucose, implanted, non-adjunctive use
    Medical Specialty
    Unknown
    Advisory Committee
    Clinical Chemistry
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    November 25, 2019
    Date Received
    July 3, 2019
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Postapproval Study Protocol
    Expedited Review
    N

    Advisory Committee Statement

    Approval of the protocol for the post-approval study (PAS) referenced above. The PAS protocol has been submitted to comply with the conditions of approval outlined in our approval order for P160048/S006

    Classifications

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

    Product Code Device Name
    QHJ Sensor, Glucose, Implanted, Non-Adjunctive Use