BEUDAMED
    FDA Registration Active 🇺🇸 United States

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

    Reg #: 3006705815 · FEI: 3006705815 · Expires 2025
    View on FDA
    Products
    8
    Proprietary Names
    7
    Establishment Types
    1
    Classifications
    8

    Registration Details

    Registration Name
    Abbott Medical
    Registration Number
    3006705815
    FEI Number
    3006705815
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    LOT A INTERIOR - No. 2 RD KM 67.5, SANTANA INDUSTRIAL PARK
    City
    Arecibo
    State
    PR
    ZIP
    00612
    Country
    US

    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

    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