BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Pulse Generator, Permanent, Implantable

    PMA: P890003 · Supplement: S378 · Decision Oct 19, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    35
    Registration Numbers
    35

    Basic Information

    Device Name
    Pulse Generator, Permanent, Implantable
    Trade Name
    MyCareLink Patient Monitor, Device Command Library (DCL) , Device Data Management Application (DDMA) CareLink Express, C
    PMA Number
    P890003
    Supplement Number
    S378
    Device Class
    FDA Class 3
    Product Code
    NVZ
    Generic Name
    Pulse generator, permanent, implantable
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    October 19, 2017
    Date Received
    July 21, 2017
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for CareLink Support of Percepta/Percepta Quad, Serena/Serena Quad, and Solara/Solara Quad CRT-P MRI SureScan Implantable Pulse Generators with Cardiac Resynchronization Therapy.

    Classifications

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

    Product Code Device Name
    NVZ Pulse Generator, Permanent, Implantable