Data / Medical devices / Belgium / St. Jude Medical Coordination Center BVBA European Distribution Center

St. Jude Medical Coordination Center BVBA European Distribution Center: FDA-registered device maker in BruCargo Vlaams Brabant, Belgium, 3 510(k) clearances and 4 PMA approvals

Name: St. Jude Medical Coordination Center BVBA European Distribution Center FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

St. Jude Medical Coordination Center BVBA European Distribution Center is registered with the FDA (registration 3012552532) in BruCargo Vlaams Brabant, Belgium. It lists 16 device types. The FDA files 3 510(k) clearances and 4 PMA approvals under its listings, the newest dated May 17, 2023. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number: 3012552532
Address: BruCargo 831, BruCargo Vlaams Brabant, Belgium, 1931
Owner or operator: ABBOTT LABORATORIES (1415939)
Roles: Exporter to the US, Repackager or relabeler
First device listed: November 9, 2007
Registered through: 2027
Brand names listed: Ampere Generator, Ampere Footswitch, Ampere Generator Accessories, Ampere Generator Fiber Cord Assembly Remote, Ampere Generator Kit, Ampere Generator Software Upgrade, Ampere Remote Control, Assert-IQ 3, 3+, EL, Insertion and Incision Tools - Models DM5000, DM5300, DM5500, DM5310, DM5510, DM5320 and more

Devices it lists

Device	Product code	Class	Role	Source
Cardiac Ablation Percutaneous Catheter	LPB	3	Exporter to the US, Repackager or relabeler	accessdata.fda.gov
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation	OAE	3	Exporter to the US	accessdata.fda.gov
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter	OAD	3	Exporter to the US, Repackager or relabeler	accessdata.fda.gov
Computer, Diagnostic, Programmable	DQK	2	Exporter to the US, Repackager or relabeler	accessdata.fda.gov
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)	NIK	3	Exporter to the US	accessdata.fda.gov
Detector And Alarm, Arrhythmia	DSI	2	Repackager or relabeler	accessdata.fda.gov
Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode	OJX	3	Exporter to the US	accessdata.fda.gov
Implantable Cardioverter Defibrillator (Non-Crt)	LWS	3	Exporter to the US	accessdata.fda.gov
Implantable Pacemaker Pulse-Generator	DXY	3	Exporter to the US	accessdata.fda.gov
Implantable Pulse Generator, Pacemaker (Non-Crt)	LWP	3	Exporter to the US	accessdata.fda.gov
Pacemaker/Icd/Crt Non-Implanted Components	OSR	3	Exporter to the US	accessdata.fda.gov
Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)	NKE	3	Exporter to the US	accessdata.fda.gov
Pulse Generator, Permanent, Implantable	NVZ	3	Exporter to the US	accessdata.fda.gov
Recorder, Event, Implantable Cardiac, (Without Arrhythmia Detection)	MXC	2	Repackager or relabeler	accessdata.fda.gov
Stylet, Catheter	DRB	2	Exporter to the US	accessdata.fda.gov
Tourniquet, Nonpneumatic	GAX	1	Exporter to the US	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
May 17, 2023	K230286	Assert-IQ Insertable Cardiac Monitor	MXC	Substantially Equivalent	ABBOTT MEDICAL	accessdata.fda.gov
June 26, 2020	K201148	EnSite Precision Cardiac Mapping System v2.6, EnSite Precision Software Installation v2.6, EnSite LiveView Dynamic Display Software License	DQK	Substantially Equivalent	ABBOTT MEDICAL	accessdata.fda.gov
April 1, 2009	K090163	STYLET, MODELS 4060, 4062, 4064, 4090, 4091 AND 4078	DRB	Substantially Equivalent	St Jude Medical	accessdata.fda.gov

PMA approvals

Premarket approvals this establishment lists, with the supplements the FDA has decided since.

Approved	PMA number	Device	Product code	Supplements	Latest decision	Source
October 24, 2014	P130026	TACTICATH QUARTZ SET	OAE	99	August 7, 2026	accessdata.fda.gov
January 25, 2012	P110016	THERAPY COOL PATH DUO/ SAFIRE BLU DUO ABLATION CATHETER AND IBI 1500T9-CP V1.6 CARDIAC ABLATION GENERATOR	OAD	91	August 7, 2026	accessdata.fda.gov
June 30, 2004	P030054	ST JUDE MEDICAL EPIC HF SYSTEM	NIK	427	August 12, 2026	accessdata.fda.gov
April 30, 1993	P910023	CADENCE(R) TIERED THERAPY DEFIBRILLATION SYSTEM	LWS	461	August 12, 2026	accessdata.fda.gov

Compare with other makers

Updated August 7, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.