Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9614453

FEI Number

3002807576

Entity Name

Medtronic Europe Sarl

City/State/Country

TOLOCHENAZ Vaud, CH

Establishment Address

ROUTE DU MOLLIAU 31, Case Postale, TOLOCHENAZ Vaud 1131, CH

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Medtronic, Inc. (Owner Number: 2112641)

Owner / Operator Contact Address

710 Medtronic Parkway, Minneapolis, MN 55432, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K132649

PMA Number

N/A

All Registered Proprietary Names

Viva Quad S CRT-D Claria MRI Quad CRT-D Amplia MRI CRT-D SureScan Concerto II CRT-D Viva S CRT-D Consulta ICD Brava Viva Maximo II CRT-D Protecta XT CRT-D Brava Quadripolar CRT-D Viva Quad XT CRT-D Protecta CRT-D Consulta DF4 ICD Compia MRI Quad CRT-D SureScan Compia MRI CRT-D SureScan Viva XT CRT-D Amplia MRI Quad CRT-D SureScan Concerto ICD Claria MRI CRT-D Crome HF CRT-D MRI SureScan Crome HF Quad CRT-D MRI SureScan Cobalt XT HF Quad CRT-D MRI SureScan Cobalt HF Quad CRT-D MRI SureScan Cobalt XT HF CRT-D MRI SureScan Cobalt HF CRT-D MRI SureScan Micra Transcatheter Pacemaker System Micra TPS Micra AV TPS Micra AV2 TPS Micra VR2 TPS Transvene Lead Reveal LINQ Patient Assistant REVEAL LINQ Advisa DR MRI SureScan Advisa DR Adapta InCheck Patient Assistant Relia IPG Adapta L Adapta S Advisa SR MRI SureScan Versa DR IPG Sensia DR IPG Azure XT DR MRI Azure S SR MRI Azure XT SR MRI Azure S DR MRI CareLink SmartSync Azure Astra Application Sphera DR MRI Attesta L DR MRI Attesta SR MRI Attesta S DR MRI Attesta DR MRI Sphera SR MRI Sphera L DR MRI Sensia IPG Analyzer Adapter Prodigy IPG Medtronic CareLink Monitor Service Kit Adapter Cable Sterile Plastic Sleeve CapSure Lead CareLink Express Mobile System - Android CapSure VDD-2 Lead CareLink Express Monitor ECG Port Plug ECG Output Adapter CareLink Wireless Network Adapter Card Program Interface Cable CareLink Express Mobile System - iOS CareLink Encore Programmer Analyzer Cable ECG Cable Lead Analyzer MyCareLink Patient Monitor CardioSight Reader CareLink Encore Programmer RF Head CareLink Programmer RF Head Medtronic CareLink Programmer CareLink SmartSync Power Cord 249705 CareLink SmartSync Patient Connector 24967 CareLink SmartSync Base 24970A CareLink SmartSync PSA Application CareLink SmartSync Common Application iOS CareLink SmartSync Power Supply 249701 Integrated Diagnostics Data Calculation Module Model 5242 Instrument Command Library (ICL)Device Command Library (DCL) Reveal DX Reveal XT Reveal LINQ Insertion Tools REVEAL LINQ

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NVZ	Pulse Generator, Permanent, Implantable	Unknown	Class 3	N/A	2002-11-22
NIK	Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)	Unknown	Class 3	N/A	2002-11-22
KRG	Programmer, Pacemaker	Cardiovascular	Class 3	870.3700	2002-11-22
LWS	Implantable Cardioverter Defibrillator (Non-Crt)	Unknown	Class 3	N/A	2002-11-22
OSR	Pacemaker/Icd/Crt Non-Implanted Components	Unknown	Class 3	N/A	2002-11-22
NKE	Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)	Unknown	Class 3	N/A	2002-11-22
PNJ	Leadless Pacemaker	Cardiovascular	Class 3	870.3610	2016-04-07
OSR	Pacemaker/Icd/Crt Non-Implanted Components	Unknown	Class 3	N/A	2016-04-07
LWS	Implantable Cardioverter Defibrillator (Non-Crt)	Unknown	Class 3	N/A	2009-06-09
MXD	Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection)	Cardiovascular	Class 2	870.1025	2021-07-22
DSI	Detector And Alarm, Arrhythmia	Cardiovascular	Class 2	870.1025	2015-05-29
MXD	Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection)	Cardiovascular	Class 2	870.1025	2016-05-04
NVN	Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes	Unknown	Class 3	N/A	2007-01-24
NVZ	Pulse Generator, Permanent, Implantable	Unknown	Class 3	N/A	2007-01-24
LWS	Implantable Cardioverter Defibrillator (Non-Crt)	Unknown	Class 3	N/A	2007-01-24
LWP	Implantable Pulse Generator, Pacemaker (Non-Crt)	Unknown	Class 3	N/A	2007-01-24
DXY	Implantable Pacemaker Pulse-Generator	Cardiovascular	Class 3	870.3610	2007-01-24
NKE	Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)	Unknown	Class 3	N/A	2007-01-24
OSR	Pacemaker/Icd/Crt Non-Implanted Components	Unknown	Class 3	N/A	2007-01-24
NVZ	Pulse Generator, Permanent, Implantable	Unknown	Class 3	N/A	2007-01-24
DXY	Implantable Pacemaker Pulse-Generator	Cardiovascular	Class 3	870.3610	2007-01-24
KRG	Programmer, Pacemaker	Cardiovascular	Class 3	870.3700	2007-01-24
LWP	Implantable Pulse Generator, Pacemaker (Non-Crt)	Unknown	Class 3	N/A	2007-01-24
DSI	Detector And Alarm, Arrhythmia	Cardiovascular	Class 2	870.1025	2007-11-29
MXD	Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection)	Cardiovascular	Class 2	870.1025	2014-02-18

Official Correspondent

No official correspondent registered.

US Agent Details

Carrie Schleis Email: carrie.l.schleis@medtronic.com Phone: (612) 8101586

Related Public Records

Same Entity

Medtronic, Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

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3007042319	HeartWare, Inc.	Miami Lakes, FL, US
3004497303	MEDTRONIC MEXICO EG	EMPALME Sonora, MX
3015192387	CATHWORKS	Newport Beach, CA, US
3004185781	Medtronic, Inc.	Tempe, AZ, US
3012520654	MEDTRONIC, INC.	Billerica, MA, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K103464	Medtronic, Inc.	PACIFIC XTREME PTCA BALLOON DILATATION CATHETER	2010-12-22
K111339	Medtronic, Inc.	HEMOSTASIS MANAGMENT SYSTEM PLUS (HMS-PLUS)	2011-06-08
K253516	ABBOTT MEDICAL	Assert-IQ (DM5100)	2025-12-18
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

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
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-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.
Z-0017-2011	Boston Scientific CRM Corp	3	Guidant, Vitality HE ICD, Model: T180DDR, Sterile Lot, Guidant Corporation, Cardiac Rhythm Management, 4100 Hamline Avenue North, St. Paul, MN 55112-5798.

Similar Registrations

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9614453. Last updated year: 2026. Please use registration number 9614453 when referencing this establishment in official correspondence.