Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2017865

FEI Number

2017865

Entity Name

ABBOTT MEDICAL

City/State/Country

Sylmar, CA, US

Establishment Address

15900 Valley View Court, Sylmar, CA 91342, 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

N/A

PMA Number

P950022

All Registered Proprietary Names

DS2C022, DS2C023, DS2C024, DS2C025, DS2C026, DS2C027, DS2C028,DS2C029, DS2C030 CPS Direct Universal Slittable Outer Catheter, Models DS2C018, DS2C019, DS2C020, DS2C021 Zenex MRI PM1283 St Jude Medical MR Conditional Pacemaker System Zenex MRI PM2283 Anthem Relieve Quadra MitraClip G5 Steerable Guide Catheter CPS Direct PL CPS Direct PL VBT Renal Guide Catheter MitraClip Steerable Guide Catheter TriClip G5 Steerable Guide Catheter MitraClip G4 Steerable Guide Catheter TriClip Steerable Guide Catheter CPS Direct Mediguide Enabled Outer Catheter Models - DS2M021, DS2M022, DS2M023 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 myCardioMEMS Patient Application for the CardioMEMS HF System Merlin.net web application Merlin.net web database Merlin Data System Merlin.net Web Application and Database CPS Direct Universal Slittable Outer Guide Catheter (Redesign) (DS2C029) Magnet, model 3111 Merlin Patient Care System Software Model 3330 Version 18.1.1 Quadra Allure MP Frontier, Frontier II, Anthem Family of CRT-PS Confirm Rx Peel Away Introducer kit replacement syringe accessory Models 405104, 405108, 405112, 405116, 405118, 405119, 405120, 40 CPS Excel MediGuide Enabled Guidewire, Model DS2M033, DS2M027, DS2M028, DS2M029, DS2M030 IS-1/Quadripolar Terminal Cap Aveir Retrieval Catheter - Model LSCR111 SJM Confirm Implantable Cardiac Monitor, Model DM2100 Merlin.net VDE MN7000 with AI Stylet Models 4060, 4062, 4064. 4090, 4091, 4078 SJM Confirm ICM Model DRM2100, SJM Confirm PA Model DM2100A PSA Cables and Adapters CPS AIM Universal II Slittable Inner Catheter DS2N100-59, DS2N100-65, DS2N101-59, DS2N101-65, DS2N102-59, DS2N102-65, DS2N103-65, DS2N104-65 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 Confirm Rx 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 myMerlin Mobile Application, Model APP1001 Nanostim Introducer Kit Endurity family of pacemakers Fortify ST and Fortify Assura ST AnalyST Accel Fortify Assura Ellipse and Ellipse ST Fortify Confirm Implantable Cardiac Monitor and Patient Activator SJM CONFIRM MODEL DM2100 IMPLANTABLE CARDIAC MONITOR AND MODEL DM2100A PATIENT ACTIVATOR CPS Excel MediGuide Guidewire CPS Excel MediGuide Enabled Guidewire Models - DS2M031, DS2M032 SJM Confirm Implantable Cardiac Monitor (MR Conditional) Agilis HisPro Steerable Catheter With Electrodes Model DS3H010-38 CPS Direct SL II Slittable Outer Catheter DS2C001, DS2C002, DS2C003, DS2C004, DS2C005, DS2C006, DS2C011, DS2C012, DS2C013, DS2C014, DS2C015 CPS Universal II Slitter Model DS2A004 CPS Universal Slitter Model DS2A003 CPS Aim MediGuide Enabled Inner Catheter Models - DS2M051, DS2M052, DS2M053, DS2M054, DS2M055 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 Aveir Introducer models LSN25301, LSN25501 CPS Direct MediGuide Enabled Outer Catheter Models - DS2M041, DS2M042, DS2M043, DS2M044 Merlin Patient Care System Software Model 3330 Version 18.1.1 Regency family of pacemakers Confirm Rx Confirm Rx Nanostim Introducer Kit Endurity MRI and Assurity MRI families of pacemakers ACCENT ST MRI Endurity Core Accent MRI Jot Dx Insertable Cardiac Monitor CardioMEMS HF System CardioMEMS Hospital Electronics System CardioMEMS Patient Electronics System Merlin.net Patient Care Network Heart Failure Portal CardioMEMS PA Sensor and Delivery System CardioMEMS Hospital System CardioMEMS HERO Device Merlin PSA Patient Cable EX 3150, Cable Adapter EX3170, "M" Adapter EX3180 Assert-IQ 3, 3+, EL, Insertion and Incision Tools - Models DM5000, DM5300, DM5500, DM5310, DM5510, DM5320 Adapting sleeve kit model 4023 Passive Plus and Isoflex Lead Families, Passive Plus DX Endocardial Steroid Eluting, Passive Fixation Pacing Leads CPS Aim SL Slittable Inner Catheter Models DS2N021-59, DS2N021-65, DS2N022-59, DS2N022-65, DS2N023-59, DS2N023-65, DS2N024-65, DS2N025-65 Optisure High Voltage Lead Family Durata, Durata DF4 Transvenous Defibrillation Leads

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2014-11-21
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
NKE	Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)	Unknown	Class 3	N/A	2021-01-08
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2012-05-18
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2012-07-17
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
OUG	Medical Device Data System	General Hospital	Class 1	880.6310	2012-03-02
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2023-11-15
DTG	Magnet, Test, Pacemaker	Cardiovascular	Class 1	870.3690	2024-11-06
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
MXC	Recorder, Event, Implantable Cardiac, (Without Arrhythmia Detection)	Cardiovascular	Class 2	870.2800	2021-01-04
DSI	Detector And Alarm, Arrhythmia	Cardiovascular	Class 2	870.1025	2021-01-04
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2023-03-08
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2014-11-21
DTD	Pacemaker Lead Adaptor	Cardiovascular	Class 2	870.3620	2013-02-25
MMX	Device, Percutaneous Retrieval	Cardiovascular	Class 2	870.5150	2022-04-06
MXC	Recorder, Event, Implantable Cardiac, (Without Arrhythmia Detection)	Cardiovascular	Class 2	870.2800	2013-02-25
DSH	Recorder, Magnetic Tape, Medical	Cardiovascular	Class 2	870.2800	2013-02-25
DXH	Transmitters And Receivers, Electrocardiograph, Telephone	Cardiovascular	Class 2	870.2920	2013-02-25
MXD	Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection)	Cardiovascular	Class 2	870.1025	2025-12-02
DRB	Stylet, Catheter	Cardiovascular	Class 2	870.1380	2013-02-25
MXC	Recorder, Event, Implantable Cardiac, (Without Arrhythmia Detection)	Cardiovascular	Class 2	870.2800	2013-02-25
DTA	Tester, Pacemaker Electrode Function	Cardiovascular	Class 2	870.3720	2010-10-22
DSA	Cable, Transducer And Electrode, Patient, (Including Connector)	Cardiovascular	Class 2	870.2900	2010-10-22
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
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2022-07-18
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2008-12-12
MXC	Recorder, Event, Implantable Cardiac, (Without Arrhythmia Detection)	Cardiovascular	Class 2	870.2800	2021-01-04
DSI	Detector And Alarm, Arrhythmia	Cardiovascular	Class 2	870.1025	2021-01-04
DWS	Instruments, Surgical, Cardiovascular	Cardiovascular	Class 1	870.4500	2001-01-17
MXC	Recorder, Event, Implantable Cardiac, (Without Arrhythmia Detection)	Cardiovascular	Class 2	870.2800	2024-04-30
DSI	Detector And Alarm, Arrhythmia	Cardiovascular	Class 2	870.1025	2024-04-30
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2016-11-01
NVZ	Pulse Generator, Permanent, Implantable	Unknown	Class 3	N/A	2015-02-06
MXC	Recorder, Event, Implantable Cardiac, (Without Arrhythmia Detection)	Cardiovascular	Class 2	870.2800	2008-08-20
DSH	Recorder, Magnetic Tape, Medical	Cardiovascular	Class 2	870.2800	2008-08-20
DXH	Transmitters And Receivers, Electrocardiograph, Telephone	Cardiovascular	Class 2	870.2920	2008-08-20
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2012-07-17
MXC	Recorder, Event, Implantable Cardiac, (Without Arrhythmia Detection)	Cardiovascular	Class 2	870.2800	2013-02-25
MXD	Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection)	Cardiovascular	Class 2	870.1025	2025-12-19
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	2013-02-25
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2014-12-23
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
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2022-01-14
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2014-12-23
NIK	Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)	Unknown	Class 3	N/A	2007-11-09
LWS	Implantable Cardioverter Defibrillator (Non-Crt)	Unknown	Class 3	N/A	2007-11-09
KRG	Programmer, Pacemaker	Cardiovascular	Class 3	870.3700	2007-11-09
LWP	Implantable Pulse Generator, Pacemaker (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
NVZ	Pulse Generator, Permanent, Implantable	Unknown	Class 3	N/A	2007-11-09
DXY	Implantable Pacemaker Pulse-Generator	Cardiovascular	Class 3	870.3610	2007-11-09
MXC	Recorder, Event, Implantable Cardiac, (Without Arrhythmia Detection)	Cardiovascular	Class 2	870.2800	2021-01-04
DSI	Detector And Alarm, Arrhythmia	Cardiovascular	Class 2	870.1025	2021-01-04
DSI	Detector And Alarm, Arrhythmia	Cardiovascular	Class 2	870.1025	2021-01-04
MXC	Recorder, Event, Implantable Cardiac, (Without Arrhythmia Detection)	Cardiovascular	Class 2	870.2800	2021-01-04
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2016-11-01
LWP	Implantable Pulse Generator, Pacemaker (Non-Crt)	Unknown	Class 3	N/A	2015-02-06
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
MOM	System, Hemodynamic, Implantable	Unknown	Class 3	N/A	2018-02-12
DTA	Tester, Pacemaker Electrode Function	Cardiovascular	Class 2	870.3720	2013-02-25
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
DTD	Pacemaker Lead Adaptor	Cardiovascular	Class 2	870.3620	2013-02-25
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
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

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-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-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-0029-2018	St Jude Medical Inc.	3	Anthem Model Numbers: PM3210, PM3212; Allure/Relieve Model Numbers: PM3222, PM3242, PM3262, PM3542, PM3224, PM3244 Implantation of a single-chamber pulse generator, dual-chamber pulse generator, or CRT-P is indicated in one or more of the following permanent conditions: Syncope, Presyncope, Fatigue, Disorientation, Or any combination of those symptoms. Implantation of a CRT-P is indicated for: Maintaining synchrony of the left and right ventricles in patients who have undergone an AV nodal ablation for chronic atrial fibrillation and have NYHA Class II or III heart failure. The reduction of the symptoms of moderate to severe heart failure (NYHA Class III or IV) in those patients who remain symptomatic despite stable, optimal medical therapy, and have a left ventricular ejection fraction d35% and a prolonged QRS duration
Z-0030-2018	St Jude Medical Inc.	3	Assurity Model Numbers: PM1240, PM2240; Assurity + Model Number: PM2260; Accent Model Numbers: PM1210, PM2210, PM1222, PM2212; Accent MRI Model Numbers: PM1224, PM2218, PM2224 Implantation of a single-chamber pulse generator, dual-chamber pulse generator, or CRT-P is indicated in one or more of the following permanent conditions: Syncope, Presyncope, Fatigue, Disorientation, Or any combination of those symptoms. Implantation of a CRT-P is indicated for: Maintaining synchrony of the left and right ventricles in patients who have undergone an AV nodal ablation for chronic atrial fibrillation and have NYHA Class II or III heart failure. The reduction of the symptoms of moderate to severe heart failure (NYHA Class III or IV) in those patients who remain symptomatic despite stable, optimal medical therapy, and have a left ventricular ejection fraction d35% and a prolonged QRS duration
Z-0031-2018	St Jude Medical Inc.	3	Assurity MRI Model Numbers: PM1272, PM2272 Implantation of a single-chamber pulse generator, dual-chamber pulse generator, or CRT-P is indicated in one or more of the following permanent conditions: Syncope, Presyncope, Fatigue, Disorientation, Or any combination of those symptoms. Implantation of a CRT-P is indicated for: Maintaining synchrony of the left and right ventricles in patients who have undergone an AV nodal ablation for chronic atrial fibrillation and have NYHA Class II or III heart failure. The reduction of the symptoms of moderate to severe heart failure (NYHA Class III or IV) in those patients who remain symptomatic despite stable, optimal medical therapy, and have a left ventricular ejection fraction d35% and a prolonged QRS duration
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.
Z-0033-2018	St Jude Medical Inc.	3	Merlin@Home Software Model EX2000 v8.2.2 for Merlin@Home Transmitter Models EX1150, EX1150W, EX1100, and EX1100W. The Merlin@home Transmitters are a component of St. Jude Medicals (SJM) Remote Care System. These Merlin@home transmitters are used to retrieve information from the SJM implantable medical device (IMD) using RF telemetry. The data is then sent back to the Merlin.net Patient Care Network through a built-in modem or, alternatively, through a USB cellular adapter or a USB based Broadband Kit. The transmitted data enables clinicians to remotely monitor a patients IMD using a secure, encrypted, password-protected web site, thus reducing the number of in-clinic visits a patient needs to make to their physician. The transmitter monitors the patients device daily between scheduled follow-ups and can alert a clinician if it detects anything out of the norm.
Z-0034-2018	St Jude Medical Inc.	3	PM1214 NUANCE SR RF; PM1230 and PM2230 NUANCE MRI; PM2214 NUANCE DR RF These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders.
Z-0035-2018	St Jude Medical Inc.	3	PM1226 ACCENT ST MRI SR RF and PM2222 ACCENT ST These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders.
Z-0036-2018	St Jude Medical Inc.	3	PM 1250 and PM 2250 ZENEX; PM1282 and PM2282 ZENEX MRI These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders.
Z-0037-2018	St Jude Medical Inc.	3	PM 1260 ASSURITY + These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders.
Z-0038-2018	St Jude Medical Inc.	3	PM3544 QUADRA RELIEVE and PM3562 QUADRA ALLURE MP These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders
Z-0551-2025	Abbott Medical	3	Merlin@home Transmitter REF EX1100 The Merlin@home" (M@h) transmitter is intended to transfer stored data from the patient s implanted heart device to Merlin.net" Patient Care Network (PCN) to facilitate remote monitoring by using inductive (EX1100 Model) or RF telemetry (EX1150 Model) to read device data and transmitting to the Merlin.net PCN server.
Z-0552-2025	Abbott Medical	3	Merlin@home with the MerlinOnDemand capability Transmitter REF EX1150 Merlin@home with the MerlinOnDemand" (MoD) capability is a transmitter configured for multiple patient use. It can receive information from an implantable heart device in unpaired mode. With MoD capability, the transmitter will retrieve full follow-up data or retrieve data for display on the Merlin.net" Patient Care Network (PCN). The MoD capability enables clinicians to do the following: . support remote care patients in emergency rooms and heart failure clinics . triage patients for in clinic follow-ups . support patients in a clinical setting with Merlin.net PCN
Z-0753-2025	Abbott Medical	3	The Merlin PCS 3650 programmer Model 3330 The Merlin PCS programmer model 3650 is a portable, dedicated programming system which operates using the Merlin PCS Model 3330 software and is designed to interrogate, program, display data from, and test Abbott Medical implantable devices and leads.
Z-1557-2025	Abbott Medical	3	Aveir DR Leadless Pacemaker (LP) Ventricular Device REF LSP202V UDI-DI code: 05415067040725 REF LSP112V UDI-DI code: 05415067034472 The Aveir leadless pacemaker system supports the implantation and use of an Aveir Leadless Pacemaker (LP) within the targeted chamber(s) of the heart for monitoring a patient s heart rate and providing rate responsive bradycardia pacing therapy to regulate heart rate.
Z-1695-2024	Abbott Medical	3	Abbott Aveir Leadless Pacemaker, REF: LSP112V, STERILEEO

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2017865. Last updated year: 2026. Please use registration number 2017865 when referencing this establishment in official correspondence.