BEUDAMED
    FDA Registration Active 🇲🇾 Malaysia

    Abbott Medical

    Reg #: 3008494315 · FEI: 3008377825 · Expires 2026
    View on FDA
    Products
    15
    Proprietary Names
    58
    Establishment Types
    1
    Classifications
    15

    Registration Details

    Registration Name
    Abbott Medical
    Registration Number
    3008494315
    FEI Number
    3008377825
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Plot 102, Lebuhraya Kampung Jawa, Bayan Lepas Industrial Zone
    City
    Penang Pulau Pinang
    Country
    MY

    Regulatory Submissions

    510(k) Number
    K212206
    PMA Number
    P960013

    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
    Recorder, Event, Implantable Cardiac, (Without Arrhythmia Detection) MXC
    Detector And Alarm, Arrhythmia DSI
    Pulse Generator, Permanent, Implantable NVZ
    Permanent Pacemaker Electrode DTB
    Implantable Pacemaker Pulse-Generator DXY
    Permanent Defibrillator Electrodes NVY
    Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes NVN
    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
    Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode OJX
    Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P) NKE
    Programmer, Pacemaker KRG
    Pulse-Generator, Single Chamber, Sensor Driven, Implantable LWO

    Proprietary Names

    Jot Dx Insertable Cardiac Monitor Assert-IQ™ 3, 3+, EL, Insertion and Incision Tools - Models DM5000, DM5300, DM5500, DM5310, DM5510, DM5320 Confirm Rx ICM Accessory Kit Suture Sleeve Accessory DS2A088 Tendril SDX, Tendril ST, Tendril STS, OptiSense, Tendril DX Leads UltiPace Bradycardia Pacing Lead Model LPA1231 Quadra Assura CRT-D, Unify Assura CRT-D Promote CRT-Ds, Stylet Kit, Merlin Patient Care System Accessories, Slit Suture Sleeve, Stylet Guide, Vein Pick Current DR, VR ICDs, Promote ICDs, Merlin Antenna 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 Flushing Tool, Merlin@home Transmitter Software, Durata Active Fixation Leads Merlin Cable Adapter, Merlin "M" Adapter, Merlin Patient System Analyzer, Slit Suture Sleeve, Merlin Patient Care System Software Model 3330 Version 18.1.1 CRT Leads, Quickflex Left Heart Leads Entrant Models - CDHFA300B, CDHFA300D, CDHFA300Q, CDHFA300T Gallant Models - CDHFA500B, CDHFA500D, CDHFA500Q, CDHFA500T Avant Models CDHFA700B, CDHFA700D, CDHFA700Q, CDHFA700T Neutrino NxT Models - CDHFA600B, CDHFA600D, CDHFA800B, CDHFA800D, CDHFA800Q Neutrino NxT Models - CDHFA600Q, CDHFA800T, CDHFA600T Lead Cap IS-1/DF-1/SJ4, Merlin Patient Care System Software, Programmer Software, Wireless USB Adapter IS4/DF4 Connector Sleeve, IS4/DF4 Plug Accessory Kit, Ellipse DR ICD, Ellipse VR ICD. Fortify Assura ICD Merlin@home Transmitter, 3-Lead ECG Cable, Current+ DR VR, ICDs, Promote+ ICDs, Current DR VR ICDs, Promote+ CRT-Ds Guidewire, Stylet, Tip Introducer/Torque Tool, Merlin Patient Care System Passive Plus and Isoflex Lead Families, Passive Plus DX Endocardial Steroid Eluting, Passive Fixation Pacing Leads Optisure High Voltage Lead Family Durata, Durata DF4 Transvenous Defibrillation Leads 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, 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 Accent; Sustain XL SC, DC, SR, DR; Identity ADX, Identity, DC, VDR, Integrity ADx XL, Integrity DR, SR, Verity ADx XL, DR, XL , DC, VDR Quadra Allure MP Frontier, Frontier II, Anthem Family of CRT-PS Pulse-generator, single chamber Zenex MRI PM1283 St Jude Medical MR Conditional Pacemaker System Zenex MRI PM2283 Confirm Rx Current DR, VR ICD, Merlin Antenna, Promote ICD Vein Pick Neutrino NxT Models - CDVRA800Q, CDVRA600Q, CDDRA800Q, CDDRA600Q, CDVRA800T, CDVRA600T, CDDRA800T, CDDRA600T Fortify VR, DR ICD, Wireless Broadband Kit, IS4/DF4 Port Plug Accessory Kit, Ellipse DR, Ellipse VR Merlin Patient Care System Software Promote+ ICD, Promote CRT-D, Promote+ CRT-D, Merlin.net Patient Care Network s/w Silicone Oil DF-1 Receptacle Plug, Hex Wrench, Entrant Models - CDDRA300Q, CDVRA300T, CDDRA300T Merlin Live Connect Software Model MLC1000 Avant Models - CDVRA700Q, CDDRA700Q, CDVRA700T, CDDRA700T Gallant Models - CDVRA500Q, CDDRA500Q, CDVRA500T, CDDRA500T Integrity ADx XL DR, DR, SR, Verity ADx XL DR, XL DC, XL SR, XL, SC, XL VDR Stylet Kit, Promote ICD Programmer Sotware,Merlin@home Tansmitter, Wireless USB Adapter, Current+ DR, VR ICD, Current DR, VR ICD IS-1 Receptacle Plus, Medical Adhesive Merlin@home Transmitter software, Durata Active Fixation Leads, Lead Cap (IS1/DF1/SJ4

    Establishment Types

    Manufacture Medical Device