BEUDAMED
    FDA PMA FDA Class 3 30-Day Notice Accepted 🇺🇸 United States

    Implantable Pulse Generator, Pacemaker (Non-Crt)

    PMA: N970003 · Supplement: S232 · Decision Nov 16, 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, ALTRUA 2, ESSENTIO, PROPONENT, ACCOLADE
    PMA Number
    N970003
    Supplement Number
    S232
    Device Class
    FDA Class 3
    Product Code
    LWP
    Generic Name
    Implantable pulse generator, pacemaker (non-CRT)
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    November 16, 2018
    Date Received
    October 19, 2018
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Addition of alternative equipment to sterilize Accolade, NG3, NG4,and EMBLEM S-ICD product families using the new sterilization cycle DEV_PROD55_02 at the Clonmel, Ireland manufacturing facility.

    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)