BEUDAMED
    FDA Registration Active 🇺🇸 United States

    AXIUM NEUROSTIMULATOR SYSTEM

    Reg #: 1627487 · FEI: 1627487 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    17
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Abbott Medical
    Registration Number
    1627487
    FEI Number
    1627487
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    6901 Preston Rd
    City
    PLANO
    State
    TX
    ZIP
    75024
    Country
    US

    Regulatory Submissions

    PMA Number
    P150004

    Owner / Operator

    Firm Name
    ABBOTT LABORATORIES
    Operator Number
    1415939
    Address
    100 ABBOTT PARK RD., D-03Q3, AP52-1
    City
    Abbott Park
    State
    IL
    Postal Code
    60064
    Country
    US

    Products

    Device Name Product Code
    Dorsal Root Ganglion Stimulator For Pain Relief PMP

    Proprietary Names

    AXIUM NEUROSTIMULATOR SYSTEM DRG External Pulse Generator, 8 Channel DRG EPG Kit Accessories Proclaim DRG Implantable Pulse Generator DRG Connector Cable St. Jude Medical Clinician Programmer App St. Jude Medical Patient Controller App DRG External Pulse Generator, 2 Port Header DRG Big Curve Delivery Sheath SlimTip™ DRG Trial Lead SlimTip™ DRG Implant Lead DRG Tunneling Tool DRG Lead Extension DRG Lead Accessories Kit DRG Small Curve Delivery Sheath DRG Curved Needle NeuroSphere Digital Health App (3876)

    Establishment Types

    Manufacture Medical Device