BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Heart-Valve, Mechanical

    PMA: P810002 · Supplement: S076 · Decision Aug 11, 2011
    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
    S076
    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
    August 11, 2011
    Date Received
    June 13, 2011
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR CHANGES TO THE SPECIFICATION RANGE FOR THE COURSES PER INCH (CPI) AND THICKNESS OF THE PTFE FABRIC USED IN THE CONSTRUCTION OF THE PTFE SEWING CUFF USED WITH THE MASTERS SERIES VALVES, AS WELL AS APPROVAL OF TWO CHANGES INTENDED TO OFFSET THE INCREASE IN THE FORCE REQUIRED FOR VALVE ROTATION (TORQUE) ASSOCIATED WITH THE FABRIC MODIFICATION. THESE PROPOSED CHANGES ARE FOR THE INCREASE IN THE DIAMETER OF THE ROTATION SPRING AND RETAINER ID AND REDUCING THE LOWER LIMIT OF TORQUE FROM 2.0 IN-OZ TO 0.2 IN-OZ.

    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