BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Heart-Valve, Mechanical

    PMA: P870038 · Supplement: S005 · Decision Jul 20, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    17
    Registration Numbers
    17

    Basic Information

    Device Name
    Heart-Valve, Mechanical
    Trade Name
    STARR-EDWARDS SILASTIC BALL PROSTHESIS,MODELS 1260 & 6120
    PMA Number
    P870038
    Supplement Number
    S005
    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
    July 20, 2005
    Date Received
    February 11, 2005
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR AN ALTERNATE SUPPLIER OF POLYETHYLENE TETRAFLUOROETHYLENE (PTFE) THREAD, NAMELY W.L. GORE, AND FOR A CHANGE FROM MULTIFILAMENT PTFE THREAD TO MONOFILAMENT PTFE THREAD USED IN THE FINAL SEWING OF THE CLOTH TO COMPLETE THE SEWING RING OF THE STARR-EDWARDS SILASTIC BALL PROSTHESIS, MODELS 1260 & 6120.

    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