BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Permanent Pacemaker Electrode

    PMA: P950037 · Supplement: S016 · Decision Oct 31, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24

    Basic Information

    Device Name
    Permanent Pacemaker Electrode
    Trade Name
    PHILOS FAMILY OF PULSE GENERATORS
    PMA Number
    P950037
    Supplement Number
    S016
    Device Class
    FDA Class 3
    Product Code
    DTB
    Generic Name
    permanent pacemaker Electrode
    Regulation Number
    870.3680
    Medical Specialty
    Cardiovascular
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    October 31, 2000
    Date Received
    October 6, 2000
    Supplement Type
    Real-Time Process
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE USE OF ALTERNATIVE COMPONENTS IN THE PHILOS FAMILY OF PULSE GENERATORS, SPECIFICALLY: 1) THE LITRONIK GMBH AND CO. MODEL LIS 3150 BATTERY; AND 2) A LOW TEMPERATURE CO-FIRE CERAMIC (LTCC) SUBSTRATE.

    Classifications

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

    Product Code Device Name
    DTB Permanent Pacemaker Electrode