BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implantable Pacemaker Pulse-Generator

    PMA: P980035 · Supplement: S020 · Decision Feb 26, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28

    Basic Information

    Device Name
    Implantable Pacemaker Pulse-Generator
    Trade Name
    MEDTRONIC KAPPA 900/800 SERIES PLUSE GENERATORS
    PMA Number
    P980035
    Supplement Number
    S020
    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
    February 26, 2002
    Date Received
    February 14, 2002
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Express GMP Supplement
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR ALTERNATE FACILITIES FOR THE MANUFACTURING, PACKAGING AND STERILIZATION OF THE MEDTRONIC KAPPA 900/800 SERIES PULSE GENERATOR PRODUCTS: MEDTRONIC BV, KERKRADE, THE NETHERLANDS AND MEDTRONIC EUROPE S.A., TOLOCHANEZ, SWITZERLAND.

    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