BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Heart-Valve, Mechanical

    PMA: P810002 · Supplement: S052 · Decision Jun 30, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    17
    Registration Numbers
    17

    Basic Information

    Device Name
    Heart-Valve, Mechanical
    Trade Name
    MASTERS SERIES VALVE: PTFE SEWING CUFF
    PMA Number
    P810002
    Supplement Number
    S052
    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
    June 30, 2000
    Date Received
    May 22, 2000
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Postapproval Study Protocol
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL TO REMOVE THE CONDITION OF APPROVAL IN THE JULY 23,1998 APPROVAL ORDER THAT THE FIRM PROVIDE RESULTS FROM TESTS WHICH DEMONSTRATE THE LONG-TERM INTEGRITY OF THE SEWING CUFF ATTACHMENT MECHANISM OF THE ST. JUDE MEDICAL(R) MASTER SERIES VALVE MODELS.

    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