BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Programmer, Pacemaker

    PMA: P900070 · Supplement: S027 · Decision Sep 7, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    22
    Registration Numbers
    22

    Basic Information

    Device Name
    Programmer, Pacemaker
    Trade Name
    TRILOGY/SOLUS II/PARAGON III/PHOENIX III
    PMA Number
    P900070
    Supplement Number
    S027
    Device Class
    FDA Class 3
    Product Code
    KRG
    Generic Name
    Programmer, pacemaker
    Regulation Number
    870.3700
    Medical Specialty
    Cardiovascular
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    September 7, 2000
    Date Received
    August 11, 2000
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Location Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE ALTERNATE MANUFACTURING FACILITY AT INNOMEDICA, INC., MINNEAPOLIS, MN AND THE ALTERNATE STERILIZATION FACILITY ST STERIS ISOMEDIX, MINNEAPOLIS, MN.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    KRG Programmer, Pacemaker