Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012552532

FEI Number

3012552532

Entity Name

St. Jude Medical Coordination Center BVBA European Distribution Center

City/State/Country

BruCargo Vlaams Brabant, BE

Establishment Address

BruCargo 831, BruCargo Vlaams Brabant 1931, BE

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on 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

P030054

All Registered Proprietary Names

RadiStop Ampere Generator FlexAbility Ablation Catheter Sensor Enabled Ablation Connection Cable Therapy Cool Flex Ablation Catheter FlexAbility Ablation Catheter, Sensor Enabled Therapy Cool Path Duo Ablation Catheter Safire BLU Duo Ablation Catheter IBI 1500T9-CP V1.6 Cardiac Ablation Generator Ampere Generator Accessories Ampere Generator Fiber Cord Assembly Remote Ampere Generator Kit Ampere Remote Control Ampere Footswitch EnSite LiveView Dynamic Display Software License EnSite Precision Software Installation v2.6 EnSite Precision Software Upgrade v2.7.1 EnSite Precision Software Installation v.2.7 H702701 EnSite Precision Surface Electrode Kit EN0020-p EnSite Precision System Software Upgrade v.2.6.1, H702602 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, Merlin Patient Care System Software Model 3330 Version 18.1.1 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 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

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GAX	Tourniquet, Nonpneumatic	General, Plastic Surgery	Class 1	878.5900	2009-03-03
OAD	Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter	Unknown	Class 3	N/A	2012-02-06
LPB	Cardiac Ablation Percutaneous Catheter	Unknown	Class 3	N/A	2012-02-06
DQK	Computer, Diagnostic, Programmable	Cardiovascular	Class 2	870.1425	2020-06-30
DXY	Implantable Pacemaker Pulse-Generator	Cardiovascular	Class 3	870.3610	2007-11-09
OSR	Pacemaker/Icd/Crt Non-Implanted Components	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
NVZ	Pulse Generator, Permanent, Implantable	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
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
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

Official Correspondent

No official correspondent registered.

US Agent Details

Kathy Berg 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
K935043	Siemens Medical Electronics	SIEMENS CLINICAL WORK STATION	1995-04-07
K170948	Acutus Medical, Inc.	AcQMap High Resolution Imaging and Mapping System	2017-10-16
K242016	ABBOTT MEDICAL	EnSite X EP System	2024-08-09
K172182	St. Jude Medical (Now Part of the Abbott Medical)	QUANTIEN Measurement System	2017-08-18
K252013	ABBOTT MEDICAL	EnSite X EP System	2025-09-25

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0002-2016	Biosense Webster, Inc.	2	Carto 3 EP Navigation System. Electro physiology system which views of the electrical activity of the heart through real-time data on 3-D, color-coded cardiac maps.
Z-0032-05	Siemens Medical Solutions USA, Inc	2	AXIOM Sensis Programmable diagnostic computer, Model number 66 23 974.
Z-0033-05	Siemens Medical Solutions USA, Inc	2	AXIOM Sensis Programmable diagnostic computer, Model number 66 34 633.
Z-0034-05	Siemens Medical Solutions USA, Inc	2	AXIOM Sensis Programmable diagnostic computer, Model number 66 34 641
Z-0035-05	Siemens Medical Solutions USA, Inc	2	AXIOM Sensis Programmable diagnostic computer, Model number 66 34 658

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012552532. Last updated year: 2026. Please use registration number 3012552532 when referencing this establishment in official correspondence.