BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implantable Pulse Generator, Pacemaker (Non-Crt)

    PMA: P150012 · Supplement: S021 · Decision Apr 11, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    35
    Registration Numbers
    35

    Basic Information

    Device Name
    Implantable Pulse Generator, Pacemaker (Non-Crt)
    Trade Name
    ESSENTIO, PROPONENT, ACCOLADE, INGEVITY MRI'S & SLIT SUTURE SLEEVE ACCESSORY (FOR INGEVITY MRI LEADS)
    PMA Number
    P150012
    Supplement Number
    S021
    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
    April 11, 2017
    Date Received
    December 9, 2016
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for the addition of 3T MR Conditional labeling for the Image Ready MR Conditional Pacing System consisting of an Accolade MRI pacemaker with one or two INGEVITY MRI leads. Approval to expand the Image Ready System to include 1.5T MR Conditional labeling for the FINELINE II Sterox and Sterox EZ leads.

    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)