BEUDAMED
    FDA PMA FDA Class 3 Approved (Withdrawn) 🇺🇸 United States

    Heart-Valve, Non-Allograft Tissue

    PMA: P060025 · Decision Oct 30, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    19
    Registration Numbers
    19

    Basic Information

    Device Name
    Heart-Valve, Non-Allograft Tissue
    Trade Name
    ATS 3F AORTIC BIOPROSTHESIS
    PMA Number
    P060025
    Device Class
    FDA Class 3
    Product Code
    LWR
    Generic Name
    heart-valve, non-allograft tissue
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved (Withdrawn)
    Decision Code
    APWD
    Decision Date
    October 30, 2008
    Date Received
    September 27, 2006
    Expedited Review
    N
    Docket Number
    08M-0594

    Advisory Committee Statement

    APPROVAL FOR THE ATS 3F AORTIC BIOPROSTHESIS, MODEL 1000 (SIZES 21, 23, 25, 27 AND 29 MM). THE DEVICE IS INDICATED FOR THE REPLACEMENT OF DISEASED, DAMAGED, OR MALFUNCTIONING NATIVE OR PROSTHETIC AORTIC VALVES.

    Classifications

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

    Product Code Device Name
    LWR Heart-Valve, Non-Allograft Tissue