BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Heart-Valve, Mechanical

    PMA: P810002 · Supplement: S058 · Decision Feb 14, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    17
    Registration Numbers
    17

    Basic Information

    Device Name
    Heart-Valve, Mechanical
    Trade Name
    SJM MASTERS SERIES AORTIC VALVED PROSTHESIS WITH VASCUTEK GELWEAVE VALSALVA GRAFT (MODEL VAVGJ-515)
    PMA Number
    P810002
    Supplement Number
    S058
    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
    February 14, 2005
    Date Received
    January 3, 2005
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR AN ADDITIONAL CONFIGURATION OF THE AORTIC VALVED GRAFT USING THE SJM MASTERS SERIES AORTIC VALVED PROSTHESIS WITH THE VASCUTEK GELWEAVE VALSALVA GRAFT. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME SJM MASTERS SERIES AORTIC VALVED PROSTHESIS WITH VASCUTEK GELWEAVE VALSALVA GRAFT (MODEL VAVGJ-515) AND IS INDICATED FOR THE REPLACEMENT OF A MALFUNCTIONING NATIVE OR PROSTHETIC AORTIC HEART VALVE AND 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