Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013288201

FEI Number

3013288201

Entity Name

ABBOTT MEDICAL

City/State/Country

Minnetonka, MN, US

Establishment Address

14901 Deveau Pl. Building 2, Minnetonka, MN 55345, US

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

Expiration Date (Year)

2026

510(k) Number

K082932

PMA Number

N/A

All Registered Proprietary Names

Optisure High Voltage Lead Family Durata, Durata DF4 Transvenous Defibrillation Leads Pacel Bipolar Pacing Catheter Disposable Patient Cables SJM Adapter Cable Connectors SJM Patient Cable 401758,401759,401760 SJM Threshold Cable 401748 SJM Epicardial Cable 401777, 401778 Abbott Medical Threshold Cable Abbott Medical Epicardial Cable Abbott Medical Patient Cable Pulse-generator, single chamber 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 CPS Direct PL Peelable Outer Guide Catheter, Accessory Valve Bypass Tools 410170, 410171, 410172, 410173, 410174, 410175, 410176, 410177, 410180, 410181, 410182, 410183, 410184, 410185 410220, 410221, 410222, 410223, 410225, 410193, 410194 410186, 410187, 410210, 410211, 410212, 410213, 410214, 410215, 410216, 410224, 410217, 410218, 410219 DS2C022, DS2C023, DS2C024, DS2C025, DS2C026, DS2C027, DS2C028,DS2C029, DS2C030 CPS Direct Universal Slittable Outer Catheter, Models DS2C018, DS2C019, DS2C020, DS2C021 ECG Adapter Pacel Flow Directed Pacing Catheter Pacel Flow Directed Pacing Catheter 401761, 401762, 401763, 401764 Agilis HisPro Steerable Catheter With Electrodes Model DS3H010-38 CPS AIM Universal II Slittable Inner Catheter DS2N100-59, DS2N100-65, DS2N101-59, DS2N101-65, DS2N102-59, DS2N102-65, DS2N103-65, DS2N104-65 Aveir Link Module - Model LSL02 Aveir Delivery Catheter - Models LSCD201, LSCD111 Aveir Leadless Pacemaker - Models LSP112V, LSP201A, LSP202V Aveir Patient Transmitter Software - Model LSRM1000 Aveir Patient Transmitter - Model LSRM01 Aveir Patient Transmitter Wired Electrodes - Model LSRMC01 AVEIR AR 2 Leadless Pacemaker - Model LSP203A CPS Slitter, Model DS2A003 Agilis HisPro Slitter, Model DS3A001 Helix Locking Tool (HLT), Model A001HELX CPS Universal II Slitter, Model DS2A006 CPS 3D Plus Slitter, Model DS4A001 Pacel Bipolar Pacing Catheter 401765, 401775, 401766, 401776, 401767, 401768, 401769, 401770, 401771, 401772, 401773 Aveir Retrieval Catheter - Model LSCR111 Zenex MRI PM1283 St Jude Medical MR Conditional Pacemaker System Zenex MRI PM2283 SJM Threshold Cable SJM Patient Cable Abbott Medical Patient Cable Abbott Medical Threshold Cable Pacel 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 CPS Direct SL II Slittable Outer Catheter Models - DS2C007, DS2C017 CPS Direct MediGuide Enabled Outer Catheter Models - DS2M041, DS2M042, DS2M043, DS2M044 Suture Sleeve Accessory DS2A088 Tendril SDX, Tendril ST, Tendril STS, OptiSense, Tendril DX Leads UltiPace Bradycardia Pacing Lead Model LPA1231 CPS Excel MediGuide Enabled Guidewire, Model DS2M033, DS2M027, DS2M028, DS2M029, DS2M030 CPS Aim Universal Slittable Inner Catheter, Models DS2N026-59, DS2N027-59, DS2N028-59, DS2N026-65, DS2N027-65 CPS Aim Universal Slittable Inner Catheter, Models DS2N028-65, DS2N029-65, DS2N030-65 CPS Aim SL Slittable Inner Catheter Models DS2N021-59, DS2N021-65, DS2N022-59, DS2N022-65, DS2N023-59, DS2N023-65, DS2N024-65, DS2N025-65 Merlin Patient Care System Software Model 3330 Version 18.1.1 Quadra Allure MP Frontier, Frontier II, Anthem Family of CRT-PS CPS Direct Mediguide Enabled Outer Catheter Models - DS2M021, DS2M022, DS2M023 Passive Plus and Isoflex Lead Families, Passive Plus DX Endocardial Steroid Eluting, Passive Fixation Pacing Leads CPS 4F Slitter Model DS2A000, CPS Valve Bypass Tool (Aim SL) Model DS2A002

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
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
LDF	Electrode, Pacemaker, Temporary	Cardiovascular	Class 2	870.3680	2012-12-06
DSA	Cable, Transducer And Electrode, Patient, (Including Connector)	Cardiovascular	Class 2	870.2900	2007-12-11
NIK	Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)	Unknown	Class 3	N/A	2007-11-09
LWO	Pulse-Generator, Single Chamber, Sensor Driven, Implantable	Unknown	Class 3	N/A	2007-11-09
LWP	Implantable Pulse Generator, Pacemaker (Non-Crt)	Unknown	Class 3	N/A	2007-11-09
LWS	Implantable Cardioverter Defibrillator (Non-Crt)	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
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
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2008-12-12
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2014-11-21
LDF	Electrode, Pacemaker, Temporary	Cardiovascular	Class 2	870.3680	2007-12-11
LDF	Electrode, Pacemaker, Temporary	Cardiovascular	Class 2	870.3680	2021-02-05
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2020-06-03
DRA	Catheter, Steerable	Cardiovascular	Class 2	870.1280	2020-06-03
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2022-07-18
OSR	Pacemaker/Icd/Crt Non-Implanted Components	Unknown	Class 3	N/A	2022-04-06
PNJ	Leadless Pacemaker	Cardiovascular	Class 3	870.3610	2022-04-06
DWS	Instruments, Surgical, Cardiovascular	Cardiovascular	Class 1	870.4500	2001-01-17
LDF	Electrode, Pacemaker, Temporary	Cardiovascular	Class 2	870.3680	2021-02-05
MMX	Device, Percutaneous Retrieval	Cardiovascular	Class 2	870.5150	2022-04-06
NVN	Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes	Unknown	Class 3	N/A	2017-01-31
LWP	Implantable Pulse Generator, Pacemaker (Non-Crt)	Unknown	Class 3	N/A	2017-01-31
DXY	Implantable Pacemaker Pulse-Generator	Cardiovascular	Class 3	870.3610	2017-01-31
DSA	Cable, Transducer And Electrode, Patient, (Including Connector)	Cardiovascular	Class 2	870.2900	2008-12-05
LDF	Electrode, Pacemaker, Temporary	Cardiovascular	Class 2	870.3680	2008-12-05
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
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2013-02-25
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2014-12-23
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
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2014-11-21
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2014-11-21
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2010-03-16
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
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2012-07-17
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
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2010-03-16

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

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
K192037	ABBOTT MEDICAL	Advisor VL Circular Mapping Catheter, Sensor Enabled	2019-09-17
K253907	ABBOTT MEDICAL	Disposable Radiofrequency Cannula	2026-04-16
K230934	ABBOTT MEDICAL	ViewFlex Eco Reprocessed ICE Catheter	2023-05-03
K251211	ABBOTT MEDICAL	ViewFlex Xtra ICE Catheter; ViewFlex Eco Reprocessed ICE Catheter; Advisor HD Grid Mapping Catheter, Sensor Enabled; Advisor HD Grid X Mapping Catheter, Sensor Enabled; Agilis NxT Steerable Introducer; Agilis NxT Steerable Introducer Dual-Reach	2025-05-23
K192019	ABBOTT MEDICAL	Dragonfly OpStar Imaging Catheter, AptiVue Software version E.5.1	2019-11-08

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0002-2007	Guidant Corporation	3	Guidant Zoom Latitude Programming System, Model 3120, Programmer/Recorder/Monitor (PRM). A portable cardiac rhythm management system designed to be used with Guidant implantable pulse generators. Guidant Corporation, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA.
Z-0003-2018	St Jude Medical Inc.	3	Fortify VR - Model Numbers: CD1231-40 and CD1231-40Q; Fortify ST VR, Model Numbers: CD1241-40 and CD1241-40Q; Fortify Assura VR, Model Numbers: CD1257-40, CD1257-40Q, CD1357-40C, CD1357-40Q; Fortify Assura ST VR, Model Numbers: CD1263-40, CD1263-40Q, CD1363-40C, CD1363-40Q; Fortify DR, Model Numbers: CD2231-40 and CD2231-40Q; Fortify ST DR, Model Numbers: CD2241-40 and CD2241-40Q; Fortify Assura DR, Model Numbers: CD2257-40, CD2257-40Q, CD2357-40C, CD2357-40Q; Fortify Assura ST DR, Model Numbers: CD2263-40, CD2263-40Q, CD2363-40C, CD2363-40Q Product Usage Fortify and Fortify Assura implantable cardioverter defibrillators (ICDS) are intended to provided ventricular anti-tachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmias. The devices may also be programmed to provide single or dual chamber bradycardia pacing
Z-0037-2012	Boston Scientific CRM Corp	3	LATITUDE Paceart Integration Software, version 1.00 Model 6472. LATITUDE Paceart Integration is software and therefore does not have any serial numbers. However, the software version affected is version 1.00 and is distributed on USB pen drives. These pen drives are lot number controlled and denoted as Model 6493. When used in conjunction with the LATITUDE EMR Integration software transfers data files from the Boston Scientific LATITUDE Patient Management system to a clinic's Paceart system.
Z-0004-2018	St Jude Medical Inc.	3	Unify, Model Numbers: CD3231-40 and CD3231-40Q; Unify Quadra, Model Numbers: CD3249-40 and CD3249-40Q; Unify Assura, Model Numbers: CD3257-40, CD3257-40Q, CD3357-40C, CD3357-40Q; Quadra Assura, Model Numbers: CD3265-40, CD3265-40Q, CD3365-40C, CD3365-40Q; Quadra Assura MP, Model Numbers: CD3269-40, CD3269-40Q, CD3369-40C, CD3369-40Q Unify and Unify Assura cardiac resynchronization therapy defibrillators (CRTDs) are intended to provide ventricular anti-tachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. The devices may also be programmed to provide single or dual chamber bradycardia pacing, in additional to cardiac resynchronization therapy via left ventricular pacing
Z-0032-2018	St Jude Medical Inc.	3	Merlin PCS 3650 Programmer with Model 3330 Software Version 23.1.1 The Merlin Patient Care System (PCS) Model 3650 Programmer is a portable, dedicated programming system designed to interrogate program display data and test St. Jude Medical implantable devices.

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2124215	Boston Scientific Corporation	Saint Paul, MN, US
9614453	Medtronic Europe Sarl	TOLOCHENAZ Vaud, CH

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013288201. Last updated year: 2026. Please use registration number 3013288201 when referencing this establishment in official correspondence.