BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Heart-Valve, Mechanical

    PMA: P810002 · Supplement: S057 · Decision Mar 4, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    17
    Registration Numbers
    17

    Basic Information

    Device Name
    Heart-Valve, Mechanical
    Trade Name
    ST. JUDE MEDICAL REGENT MECHANICAL HEART VALVE (AORTIC)
    PMA Number
    P810002
    Supplement Number
    S057
    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
    March 4, 2002
    Date Received
    September 7, 2001
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A MODIFIED VERSION OF THE SJM STANDARD VALVE, SIZES 19, 21, 23, 25 AND 27 MM. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME REGENT MECHANICAL HEART VALVE AND IS INDICATED AS A REPLACEMENT VALVE IN PATIENTS WITH A DISEASED, DAMAGED, OR MALFUNCTIONING AORTIC VALVE. THIS DEVICE MAY ALSO BE USED TO REPLACE A PREVIOUSLY IMPLANTED PROSTHETIC HEART VALVE.

    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