BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implantable Pulse Generator, Pacemaker (Non-Crt)

    PMA: N970003 · Supplement: S229 · Decision Jul 27, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    35
    Registration Numbers
    35

    Basic Information

    Device Name
    Implantable Pulse Generator, Pacemaker (Non-Crt)
    Trade Name
    ADVANTIO, INGENIO, VITALIO, FORMIO, ALTRUA 2, ESSENTIO, PROPONENT and ACCOLADE Pacemaker and Programmer Software Applica
    PMA Number
    N970003
    Supplement Number
    S229
    Device Class
    FDA Class 3
    Product Code
    LWP
    Generic Name
    Implantable pulse generator, pacemaker (non-CRT)
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    July 27, 2018
    Date Received
    April 30, 2018
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for firmware modifications for the Ingenio and Accolade families of pacemaker and cardiac resynchronization therapy-pacemaker pulse generators and the associated Programmer Software Applications to support the addition of features including Signal Artifact Monitor, Automatic Lead Recognition, MRI Protection Mode, and RightRate pacing.

    Classifications

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

    Product Code Device Name
    LWP Implantable Pulse Generator, Pacemaker (Non-Crt)