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    FDA PMA FDA Class 3 Approved (Withdrawn) 🇺🇸 United States

    Heart-Valve, Non-Allograft Tissue

    PMA: P970030 · Decision Nov 4, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    19
    Registration Numbers
    19

    Basic Information

    Device Name
    Heart-Valve, Non-Allograft Tissue
    Trade Name
    TORONTO SPV VALVE
    PMA Number
    P970030
    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    Approved (Withdrawn)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
    November 4, 1997
    Date Received
    July 7, 1997
    Expedited Review
    N
    Docket Number
    98M-0836

    Advisory Committee Statement

    Approval for the Toronto SPV(R) Valve, Model SPA-101, sizes 21, 23, 25, 27, and 29 mm and the Toronto SPV(R) Valve Sizer Set, Model 300SPA. The device is a tissue heart valve and is indicated for the replacement of 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