BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implantable Pulse Generator, Pacemaker (Non-Crt)

    PMA: N970003 · Supplement: S167 · Decision Oct 21, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    35
    Registration Numbers
    35

    Basic Information

    Device Name
    Implantable Pulse Generator, Pacemaker (Non-Crt)
    Trade Name
    ALTRUA 2, ESSENTIO, PROPONENT AND ACCOLADE
    PMA Number
    N970003
    Supplement Number
    S167
    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
    October 21, 2014
    Date Received
    July 25, 2014
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR INGENIO PACEMAKERS (ADVANTIO MODELS K062, K063, K064; INGENIO MODELS K172, K173, K174; VITALIO MODELS K272, K273, K274; FORMIO MODEL K278); INGENIO 2 PACEMAKERS (ALTRUA 2 MODEL: S701, S702, S722; ESSENTIO MODELS L100, L101, L121; PROPONENT MODELS L200, L201, L221; ACCOLADE MODELS L300, L301, L321) AND PROGRAMMER APPLICATION SOFTWARE MODEL 2869 V2.01.

    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)