BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Heart-Valve, Non-Allograft Tissue

    PMA: P040021 · Supplement: S003 · Decision May 25, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    19
    Registration Numbers
    19

    Basic Information

    Device Name
    Heart-Valve, Non-Allograft Tissue
    Trade Name
    SJM BIOCOR VALVE AND SJM BIOCOR SUPRA VALVE
    PMA Number
    P040021
    Supplement Number
    S003
    Device Class
    FDA Class 3
    Product Code
    LWR
    Generic Name
    heart-valve, non-allograft tissue
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    May 25, 2007
    Date Received
    August 7, 2006
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE ADDITION OF THE 29MM BIOCOR AORTIC VALVE; ADDITION OF SIZES 25MM AND 27MM BICOR SUPRA AORTIC VALVE; A CHANGE IN THE PACKAGE SOLUTION CONCENTRATION; A REDUCED PRE-IMPLANT RINSE TIME; A CHANGE IN THE VALE HOLDER AND HOLDER HANDLE DESIGNS; AND ADDITIONAL HEMODYNAMIC DATA FOR THE 27MM BIOCOR MITRAL VALVE.

    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