BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implantable Pacemaker Pulse-Generator

    PMA: P880086 · Supplement: S308 · Decision Jun 30, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28

    Basic Information

    Device Name
    Implantable Pacemaker Pulse-Generator
    Trade Name
    Assurity, Assurity+, Endurity, Accent family of Pacemakers
    PMA Number
    P880086
    Supplement Number
    S308
    Device Class
    FDA Class 3
    Product Code
    DXY
    Generic Name
    implantable pacemaker Pulse-generator
    Regulation Number
    870.3610
    Medical Specialty
    Cardiovascular
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    June 30, 2020
    Date Received
    November 8, 2019
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for Avant, Neutrino NxT, Gallant, and Entrant families of ICDs and CRT-Ds; myMerlinPulse mobile application; Merlin PCS 3650 Programmer Software Model 3330 v25.0.1; and Merlin.net MN5000 v7.8.

    Classifications

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

    Product Code Device Name
    DXY Implantable Pacemaker Pulse-Generator