BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implantable Pacemaker Pulse-Generator

    PMA: P880086 · Supplement: S039 · Decision Mar 12, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28

    Basic Information

    Device Name
    Implantable Pacemaker Pulse-Generator
    Trade Name
    TRILOGY SR+ MODEL 2260L & 2264L CARDIAC PULSE GENERATORS WITH THE MODEL 3023 PDX FUNCTION PACK
    PMA Number
    P880086
    Supplement Number
    S039
    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
    March 12, 1997
    Date Received
    August 14, 1996
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE TRILOGY SR+ MODEL 2260L AND 2264L CARDIAC PULSE GENERATORS WITHT HE MODEL 3023 PD(X) FUNCTION PACK

    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