BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Heart-Valve, Mechanical

    PMA: P810002 · Supplement: S054 · Decision Oct 23, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    17
    Registration Numbers
    17

    Basic Information

    Device Name
    Heart-Valve, Mechanical
    Trade Name
    ST. JUDE MEDICAL MECHANICAL HEART VALVE
    PMA Number
    P810002
    Supplement Number
    S054
    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
    October 23, 2000
    Date Received
    September 27, 2000
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A CHANGE TO THE AORTIC POLYESTER CUFF CONFIGURATION OF THE SJM(R) MASTER SERIES HP VALVE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME SJM(R) MASTER SERIES HEMODYNAMIC PLUS (HP) WITH FLEX CUFF(TM), MODEL AFHPJ-505, AVAILABLE IN AORTIC SIZES 17, 19, 21, 23, 25, AND 27 MM.

    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