BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Pulse Generator, Permanent, Implantable

    PMA: P890003 · Supplement: S188 · Decision May 11, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    35
    Registration Numbers
    35

    Basic Information

    Device Name
    Pulse Generator, Permanent, Implantable
    Trade Name
    MEDTRONIC CARELINK DEVICE DATA MANAGEMENT APPLICATION (DDMA)
    PMA Number
    P890003
    Supplement Number
    S188
    Device Class
    FDA Class 3
    Product Code
    NVZ
    Generic Name
    Pulse generator, permanent, implantable
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    May 11, 2010
    Date Received
    March 31, 2010
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR UPDATES MADE TO THE PROGRAMMER APPLICATION SOFTWARE MODEL 9995 AND THE CARELINK DEVICE DATA MANAGEMENT APPLICATION (DDMA) IN RESPONSE TO ADVERSE FIELD EVENTS.

    Classifications

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

    Product Code Device Name
    NVZ Pulse Generator, Permanent, Implantable