BEUDAMED
    FDA Registration Active 🇲🇾 Malaysia

    Programmer Sotware,Merlin@home Tansmitter, Wireless USB Adapter, Current+ DR, VR ICD, Current DR, VR ICD

    Reg #: 3008494315 · FEI: 3008377825 · Expires 2025
    View on FDA
    Products
    7
    Proprietary Names
    17
    Establishment Types
    1
    Classifications
    7

    Registration Details

    Registration Name
    Abbott Medical
    Registration Number
    3008494315
    FEI Number
    3008377825
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Plot 102, Lebuhraya Kampung Jawa, Bayan Lepas Industrial Zone
    City
    Penang Pulau Pinang
    Country
    MY

    Regulatory Submissions

    PMA Number
    P910023

    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

    US Agent

    Business Name
    Abbott Medical
    Contact Name
    Kathy Berg
    Address
    8300 East Pacesetter Way
    City
    Scottsdale
    State
    AZ
    ZIP
    85255
    Country
    US
    Email
    [email protected]
    Phone
    480 5026330

    Products

    Device Name Product Code
    Implantable Pacemaker Pulse-Generator DXY
    Pacemaker/Icd/Crt Non-Implanted Components OSR
    Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P) NKE
    Implantable Cardioverter Defibrillator (Non-Crt) LWS
    Pulse Generator, Permanent, Implantable NVZ
    Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) NIK
    Implantable Pulse Generator, Pacemaker (Non-Crt) LWP

    Proprietary Names

    Programmer Sotware,Merlin@home Tansmitter, Wireless USB Adapter, Current+ DR, VR ICD, Current DR, VR ICD Entrant Models - CDDRA300Q, CDVRA300T, CDDRA300T Silicone Oil Current DR, VR ICD, Merlin Antenna, Promote ICD Fortify VR, DR ICD, Wireless Broadband Kit, IS4/DF4 Port Plug Accessory Kit, Ellipse DR, Ellipse VR Merlin Patient Care System Software Gallant Models - CDVRA500Q, CDDRA500Q, CDVRA500T, CDDRA500T Neutrino NxT Models - CDVRA800Q, CDVRA600Q, CDDRA800Q, CDDRA600Q, CDVRA800T, CDVRA600T, CDDRA800T, CDDRA600T Merlin@home Transmitter software, Durata Active Fixation Leads, Lead Cap (IS1/DF1/SJ4 Avant Models - CDVRA700Q, CDDRA700Q, CDVRA700T, CDDRA700T Merlin Patient Care System Software Model 3330 Version 18.1.1 DF-1 Receptacle Plug, Hex Wrench, Promote+ ICD, Promote CRT-D, Promote+ CRT-D, Merlin.net Patient Care Network s/w IS-1 Receptacle Plus, Medical Adhesive Stylet Kit, Promote ICD Vein Pick Integrity ADx XL DR, DR, SR, Verity ADx XL DR, XL DC, XL SR, XL, SC, XL VDR

    Establishment Types

    Manufacture Medical Device