BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Artificial Heart

    PMA: P030011 · Supplement: S084 · Decision Apr 12, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3

    Basic Information

    Device Name
    Artificial Heart
    Trade Name
    SynCardia temporary Total Artificial Heart (TAH-t) System
    PMA Number
    P030011
    Supplement Number
    S084
    Device Class
    FDA Class 3
    Product Code
    LOZ
    Generic Name
    Artificial heart
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    April 12, 2023
    Date Received
    February 2, 2023
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for a software change to the cardiac output and fill volume calculations of the Freedom Driver.

    Classifications

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

    Product Code Device Name
    LOZ Artificial Heart