BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implantable Pacemaker Pulse-Generator

    PMA: P950037 · Supplement: S244 · Decision Jun 28, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28

    Basic Information

    Device Name
    Implantable Pacemaker Pulse-Generator
    Trade Name
    Pulse Generator, Pacemaker, Implantable with Cardiac Resynchronization (CRT-P)
    PMA Number
    P950037
    Supplement Number
    S244
    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 28, 2023
    Date Received
    December 19, 2022
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for the Amvia and Solvia family of pulse generators and cardiac resynchronization therapy pacekaer devices, as well as for updated programmer software versions PSW 2204.U and NEO 2204.U, updated Home Monitoring Service Center software version 3.55.0, and updates to the CardioMessenger Smart 4G firmware.

    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