BEUDAMED
    FDA Registration Active 🇧🇪 Belgium

    Flushing Tool, Merlin@home Transmitter Software, Durata Active Fixation Leads

    Reg #: 3012552532 · FEI: 3012552532 · Expires 2025
    View on FDA
    Products
    7
    Proprietary Names
    19
    Establishment Types
    1
    Classifications
    7

    Registration Details

    Registration Name
    St. Jude Medical Coordination Center BVBA European Distribution Center
    Registration Number
    3012552532
    FEI Number
    3012552532
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    BruCargo 831
    City
    BruCargo Vlaams Brabant
    Country
    BE

    Regulatory Submissions

    PMA Number
    P030054

    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
    Implantable Cardioverter Defibrillator (Non-Crt) LWS
    Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) NIK
    Pacemaker/Icd/Crt Non-Implanted Components OSR
    Implantable Pulse Generator, Pacemaker (Non-Crt) LWP
    Pulse Generator, Permanent, Implantable NVZ
    Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P) NKE
    Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode OJX

    Proprietary Names

    Flushing Tool, Merlin@home Transmitter Software, Durata Active Fixation Leads Merlin Patient Care System Accessories, Slit Suture Sleeve, Stylet Guide, Vein Pick IS4/DF4 Connector Sleeve, IS4/DF4 Plug Accessory Kit, Ellipse DR ICD, Ellipse VR ICD. Fortify Assura ICD QuickFlex Micro Lead, Promote Accel CRT-Ds, Fortify VD DR ICDs, Unify CRT-Ds, Merlin Antenna Adapter Promote Q CRT-Ds, Promote Quadra CRT-Ds, Quartet Lead, Unify Quadra CRT-D, Wireless Broadband Kit Merlin@home Transmitter, 3-Lead ECG Cable, Current+ DR VR, ICDs, Promote+ ICDs, Current DR VR ICDs, Promote+ CRT-Ds Entrant Models - CDHFA300B, CDHFA300D, CDHFA300Q, CDHFA300T Quadra Assura CRT-D, Unify Assura CRT-D Merlin Cable Adapter, Merlin "M" Adapter, Merlin Patient System Analyzer, Slit Suture Sleeve, Guidewire, Stylet, Tip Introducer/Torque Tool, Merlin Patient Care System Lead Cap IS-1/DF-1/SJ4, Merlin Patient Care System Software, Programmer Software, Wireless USB Adapter Promote CRT-Ds, Stylet Kit, Current DR, VR ICDs, Promote ICDs, Merlin Antenna Merlin Patient Care System Software Model 3330 Version 18.1.1 CRT Leads, Quickflex Left Heart Leads Neutrino NxT Models - CDHFA600Q, CDHFA800T, CDHFA600T Avant Models CDHFA700B, CDHFA700D, CDHFA700Q, CDHFA700T Neutrino NxT Models - CDHFA600B, CDHFA600D, CDHFA800B, CDHFA800D, CDHFA800Q Gallant Models - CDHFA500B, CDHFA500D, CDHFA500Q, CDHFA500T

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device