BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Heart-Valve, Mechanical

    PMA: P810002 · Supplement: S056 · Decision May 3, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    17
    Registration Numbers
    17

    Basic Information

    Device Name
    Heart-Valve, Mechanical
    Trade Name
    MECHANICAL HEART VALVE, MASTERS SERIES COATED AORTIC VALVED GRAFT, MODEL CAVGJ-514 00
    PMA Number
    P810002
    Supplement Number
    S056
    Device Class
    FDA Class 3
    Product Code
    LWQ
    Generic Name
    HEART-VALVE, MECHANICAL
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    May 3, 2001
    Date Received
    March 26, 2001
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR CHANGES TO THE COUNTRY OF ORIGIN OF THE BOVINE COLLAGEN USED FOR THE HEMASHIELD(R) GRAFT, WHICH IS A COMPONENT OF THE DEVICE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ST. JUDE MEDICAL(R) MECHANICAL HEART VALVE - MASTER SERIES COATED AORTIC VALVED GRAFT, MODEL CAVGJ-51400 IN SIZES 19, 21, 23, 25, 27, 29, 31, AND 33 MM, AND IS INDICATED FOR THE REPLACEMENT OF THE AORTIC VALVE AND THE ASCENDING AORTA.

    Classifications

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

    Product Code Device Name
    LWQ Heart-Valve, Mechanical