BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implantable Pacemaker Pulse-Generator

    PMA: P990001 · Supplement: S004 · Decision Nov 13, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28

    Basic Information

    Device Name
    Implantable Pacemaker Pulse-Generator
    Trade Name
    VITATRON(R) DEMA PACING SYSTEM
    PMA Number
    P990001
    Supplement Number
    S004
    Device Class
    FDA Class 3
    Product Code
    DXY
    Generic Name
    implantable pacemaker Pulse-generator
    Regulation Number
    870.3610
    Medical Specialty
    Cardiovascular
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    November 13, 2000
    Date Received
    May 17, 2000
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE DEMA PACING SYSTEM AND THE CITATRON APPLICATION SOFTWARE MODEL VSA02, VERSION 6. THE DEMA PACING SYSTEM CONSISTS OF THE FOLLOWING PULSE GENERATORS: CLARITY DDR MODELS 860, 862, 865; CLARITY SSIR MODELS 560, 562, 565; DIAMOND 3 MODEL 840; RUBY 3 MODEL 740; TOPAZ 3 MODEL 540; JADE 3 MODEL 340; VITA 2 DDR MODEL 830; VITA 2 MODEL 530.

    Classifications

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

    Product Code Device Name
    DXY Implantable Pacemaker Pulse-Generator