BEUDAMED
    FDA Registration Active 🇺🇸 United States

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

    Reg #: 3013288201 · FEI: 3013288201 · Expires 2025
    View on FDA
    Products
    7
    Proprietary Names
    19
    Establishment Types
    1
    Classifications
    7

    Registration Details

    Registration Name
    ABBOTT MEDICAL
    Registration Number
    3013288201
    FEI Number
    3013288201
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    14901 Deveau Pl. Building 2
    City
    Minnetonka
    State
    MN
    ZIP
    55345
    Country
    US

    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

    Complaint File Establishment per 21 CFR 820.198