BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implantable Pacemaker Pulse-Generator

    PMA: P890003 · Supplement: S060 · Decision Jul 21, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28

    Basic Information

    Device Name
    Implantable Pacemaker Pulse-Generator
    Trade Name
    SYNERGYST II PMA FAMILY OF IMPLANTABLE PULSE GENERATORS
    PMA Number
    P890003
    Supplement Number
    S060
    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
    July 21, 2000
    Date Received
    June 30, 2000
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE USE OF HEADER PART NUMBER 149422-002 IN THE FOLLOWING PULSE GENERATORS: PREVAIL MODEL 8085, PREVA SR MODEL 8089, PRODIGY S MODEL 8165, PRODIGY SR MODEL 8161, THERA-I S MODEL 8965I, THERA-I SR MODEL 8961I, VITATRON VISA S MODEL 115, VITATRON VISA SR MODEL 415.

    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