Abbott Medical

FDA Device Registration & Listing · Penang Pulau Pinang, MY · Registration 3008494315

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3008494315
FEI Number
3008377825
Entity Name
Abbott Medical
City/State/Country
Penang Pulau Pinang, MY
Establishment Address
Plot 102, Lebuhraya Kampung Jawa, Bayan Lepas Industrial Zone, Penang Pulau Pinang 11900, MY
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
ABBOTT LABORATORIES (Owner Number: 1415939)
Owner / Operator Contact Address
100 ABBOTT PARK RD., D-03Q3, AP52-1, Abbott Park, IL 60064, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
P030035

All Registered 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 Merlin Patient Care System Software Model 3330 Version 18.1.1 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 Merlin Patient Care System Software Model 3330 Version 18.1.1 Quadra Allure MP Frontier, Frontier II, Anthem Family of CRT-PS

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
MXC Recorder, Event, Implantable Cardiac, (Without Arrhythmia Detection) Cardiovascular Class 2 870.2800 2021-09-15
DSI Detector And Alarm, Arrhythmia Cardiovascular Class 2 870.1025 2021-09-15
MXC Recorder, Event, Implantable Cardiac, (Without Arrhythmia Detection) Cardiovascular Class 2 870.2800 2023-05-18
DSI Detector And Alarm, Arrhythmia Cardiovascular Class 2 870.1025 2023-05-18
MXC Recorder, Event, Implantable Cardiac, (Without Arrhythmia Detection) Cardiovascular Class 2 870.2800 2020-12-07
DSI Detector And Alarm, Arrhythmia Cardiovascular Class 2 870.1025 2020-12-07
NVZ Pulse Generator, Permanent, Implantable Unknown Class 3 N/A 2007-11-09
DTB Permanent Pacemaker Electrode Cardiovascular Class 3 870.3680 2007-11-09
DXY Implantable Pacemaker Pulse-Generator Cardiovascular Class 3 870.3610 2007-11-09
NVY Permanent Defibrillator Electrodes Unknown Class 3 N/A 2007-11-09
NVN Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes Unknown Class 3 N/A 2007-11-09
LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown Class 3 N/A 2007-11-09
NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown Class 3 N/A 2007-11-09
OSR Pacemaker/Icd/Crt Non-Implanted Components Unknown Class 3 N/A 2007-11-09
LWP Implantable Pulse Generator, Pacemaker (Non-Crt) Unknown Class 3 N/A 2007-11-09
NVZ Pulse Generator, Permanent, Implantable Unknown Class 3 N/A 2007-11-09
OJX Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode Unknown Class 3 N/A 2007-11-09
NKE Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P) Unknown Class 3 N/A 2007-11-09
DTB Permanent Pacemaker Electrode Cardiovascular Class 3 870.3680 2006-05-22
NVY Permanent Defibrillator Electrodes Unknown Class 3 N/A 2006-05-22
NVN Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes Unknown Class 3 N/A 2006-05-22
LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown Class 3 N/A 2007-11-09
NVY Permanent Defibrillator Electrodes Unknown Class 3 N/A 2007-11-09
DSI Detector And Alarm, Arrhythmia Cardiovascular Class 2 870.1025 2017-11-08
MXC Recorder, Event, Implantable Cardiac, (Without Arrhythmia Detection) Cardiovascular Class 2 870.2800 2017-11-08
LWP Implantable Pulse Generator, Pacemaker (Non-Crt) Unknown Class 3 N/A 2006-08-15
LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown Class 3 N/A 2006-08-15
NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown Class 3 N/A 2006-08-15
DXY Implantable Pacemaker Pulse-Generator Cardiovascular Class 3 870.3610 2006-08-15
DTB Permanent Pacemaker Electrode Cardiovascular Class 3 870.3680 2006-08-15
KRG Programmer, Pacemaker Cardiovascular Class 3 870.3700 2006-08-15
NKE Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P) Unknown Class 3 N/A 2006-08-15
NVZ Pulse Generator, Permanent, Implantable Unknown Class 3 N/A 2006-08-15
NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown Class 3 N/A 2007-11-02
LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown Class 3 N/A 2007-11-02
NKE Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P) Unknown Class 3 N/A 2007-11-02
LWP Implantable Pulse Generator, Pacemaker (Non-Crt) Unknown Class 3 N/A 2007-11-02
LWO Pulse-Generator, Single Chamber, Sensor Driven, Implantable Unknown Class 3 N/A 2007-11-02

Official Correspondent

No official correspondent registered.

US Agent Details

Kathy Berg Business: Abbott Medical Email: kathy.berg@abbott.com Phone: (480) 5026330

Related Public Records

Same Entity

ABBOTT LABORATORIES
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3004032053 Abbott S.r.l. Milan Lombardy, IT
3011706799 Abbott Medical Atlanta, GA, US
1628664 ABBOTT LABORATORIES IRVING, TX, US
3023268435 Abbott Automation Solutions GmbH Hamburg, DE
3001883144 St. Jude Medical Brasil Ltda. Belo Horizonte Minas Gerais, BR

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K891148 Del Mar Avionics MODEL 152 DELTA HOLTER ECG ANALYSIS SYSTEM 1989-05-11
K914092 Nihon Kohden America, Inc. BSM-2100A CONFIGURED PATIENT MONITOR 1992-05-28
K153473 Braemar Manufacturing, LLC Braemar Telemetry Patch System 2016-07-22
K151681 Philips Medizin Systeme Boeblingen GmbH IntelliVue Patient Monitor 2015-07-17
K150310 Philips Medizin Systeme Boeblingen GmbH IntelliVue Patient Monitor 2015-05-13

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0458-2026 Abbott Medical 3
Eterna SCS IPG (Implantable Pulse Generator), Model Number 32400
Z-0459-2026 Abbott Medical 3
Liberta RC DBS IPG (Implantable Pulse Generator), Model Number 62400
Z-0491-2025 Abbott Medical 3
Abbott Navitor Titan, Vision Technology, Transcatheter Aortic Heart Valve, 35 mm, NVRO-35, Sterile
Z-0492-2025 Abbott Medical 3
Abbott Navitor Transcatheter Aortic Heart Valve, 29 mm, NVTR-29, Sterile
Z-0493-2025 Abbott Medical 3
Abbot Navitor, Vision Technology, Transcatheter Aortic Heart Valve, 29 mm, NVRO-29, Sterile

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008494315. Last updated year: 2026. Please use registration number 3008494315 when referencing this establishment in official correspondence.
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