BEUDAMED
    FDA Registration Active 🇺🇸 United States

    CareLink Encore Programmer

    Reg #: 3003120897 · FEI: 3003120897 · Expires 2025
    View on FDA
    Products
    6
    Proprietary Names
    32
    Establishment Types
    1
    Classifications
    6

    Registration Details

    Registration Name
    MEDTRONIC SOFAMOR DANEK USA, INC.
    Registration Number
    3003120897
    FEI Number
    3003120897
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    4340 Swinnea Road
    City
    Memphis
    State
    TN
    ZIP
    38118
    Country
    US

    Regulatory Submissions

    PMA Number
    P890003

    Owner / Operator

    Firm Name
    Medtronic, Inc.
    Operator Number
    2112641
    Address
    710 Medtronic Parkway
    City
    Minneapolis
    State
    MN
    Postal Code
    55432
    Country
    US

    Products

    Device Name Product Code
    Implantable Pulse Generator, Pacemaker (Non-Crt) LWP
    Pacemaker/Icd/Crt Non-Implanted Components OSR
    Programmer, Pacemaker KRG
    Pulse Generator, Permanent, Implantable NVZ
    Implantable Pacemaker Pulse-Generator DXY
    Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P) NKE

    Proprietary Names

    CareLink Encore Programmer ECG Port Plug Program Interface Cable CardioSight Reader Medtronic CareLink Monitor CareLink Express Mobile System - iOS Medtronic CareLink Programmer CareLink Programmer RF Head ECG Output Adapter CareLink Encore Programmer RF Head Prodigy IPG MyCareLink Patient Monitor Lead Analyzer ECG Cable Service Kit Analyzer Adapter CareLink Express Mobile System - Android Adapter Cable CapSure Lead CapSure VDD-2 Lead CareLink Wireless Network Adapter Card Sterile Plastic Sleeve Analyzer Cable CareLink Express Monitor CareLink SmartSync Power Cord 249705 CareLink SmartSync Common Application iOS CareLink SmartSync Patient Connector 24967 CareLink SmartSync Base 24970A CareLink SmartSync PSA Application CareLink SmartSync Power Supply 249701 Integrated Diagnostics Data Calculation Module Model 5242 Instrument Command Library (ICL)Device Command Library (DCL)

    Establishment Types

    Manufacture Medical Device