BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Artificial Heart

    PMA: P030011 · Supplement: S081 · Decision Jun 25, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3

    Basic Information

    Device Name
    Artificial Heart
    Trade Name
    Total Artificial Heart
    PMA Number
    P030011
    Supplement Number
    S081
    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
    June 25, 2025
    Date Received
    August 10, 2022
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Postapproval Study Protocol
    Expedited Review
    N

    Advisory Committee Statement

    Approval for the protocol for the SynCardia 50cc temporary Total Artificial Heart (TAH-t) Post Approval Study.

    Classifications

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

    Product Code Device Name
    LOZ Artificial Heart