BEUDAMED
    FDA Registration Active 🇲🇾 Malaysia

    Zephyr XL SR; Accent SR, SR RF, DR, DR RF; Anthem CRT-P, RF CRT-P; Sustain XL, DC/SC; Sustain DR/SR

    Reg #: 3008494315 · FEI: 3008377825 · Expires 2025
    View on FDA
    Products
    8
    Proprietary Names
    7
    Establishment Types
    1
    Classifications
    8

    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
    P880086

    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 Pulse Generator, Pacemaker (Non-Crt) LWP
    Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) NIK
    Implantable Cardioverter Defibrillator (Non-Crt) LWS
    Permanent Pacemaker Electrode DTB
    Implantable Pacemaker Pulse-Generator DXY
    Programmer, Pacemaker KRG
    Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P) NKE
    Pulse Generator, Permanent, Implantable NVZ

    Proprietary Names

    Zephyr XL SR; Accent SR, SR RF, DR, DR RF; Anthem CRT-P, RF CRT-P; Sustain XL, DC/SC; Sustain DR/SR Medical Adhesive, Integrity Micro SR DR, ECG Adapter Cable, Accent; Sustain XL SC, DC, SR, DR; Pacing System Analyzer Wand, Victory XL DR, DR, SR; Victory AF DR; Zephyr XL DR, DR, SR; Allure RF, Allure Quadra RF, Allure, Allure Quadra, Endurity, Assurity+, and Assurity Family of Pacemakers Merlin Patient Care System Software Model 3330 Version 18.1.1 Identity ADX, Identity, DC, VDR, Integrity ADx XL, Integrity DR, SR, Verity ADx XL, DR, XL , DC, VDR

    Establishment Types

    Manufacture Medical Device