BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Artificial Heart

    PMA: P030011 · Supplement: S074 · Decision Nov 26, 2019
    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
    S074
    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
    November 26, 2019
    Date Received
    October 28, 2019
    Supplement Type
    Special (Immediate Track)
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    Approval to update labeling in the Freedom Driver System manuals and clinical training slides.

    Classifications

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

    Product Code Device Name
    LOZ Artificial Heart