Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008973940

FEI Number

3008973940

Entity Name

Medtronic Singapore Operations Pte Ltd

City/State/Country

Singapore Central Singapore, SG

Establishment Address

49 Changi South Avenue 2, Nasaco Tech Centre, Singapore Central Singapore 486056, SG

Establishment Type(s)

Repack or Relabel Medical Device,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

N/A

PMA Number

P090013

All Registered Proprietary Names

CapSureFix Lead CapSureFix Novus MRI SureScan Leads Vitatron Crystalline Lead SureFix CapSureFix Novus Leads LINQ II Insertable Cardiac Monitor (LNQ22) LINQ II Insertable Cardiac Monitor (ICM) LINQ Tool Kit LINQ II Insertable Cardiac Monitor Capsure SP Novus Vitatron Crystalline Lead CapSure Sense Adhesive Vitatron Excellence PS+ Lead stylet kit CapSure Unipolar Lead CapSure Sense MRI SureScan Leads LINQ II Insertable Cardiac Monitor Reveal LINQ LINQ II Insertable Cardiac Monitor 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 CapSureFix MRI SureScan Lead Revo MRI SureScan

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NVN	Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes	Unknown	Class 3	N/A	2007-12-06
DTB	Permanent Pacemaker Electrode	Cardiovascular	Class 3	870.3680	2007-12-06
NVY	Permanent Defibrillator Electrodes	Unknown	Class 3	N/A	2007-12-06
OUG	Medical Device Data System	General Hospital	Class 1	880.6310	2023-11-07
MXD	Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection)	Cardiovascular	Class 2	870.1025	2023-11-07
DSI	Detector And Alarm, Arrhythmia	Cardiovascular	Class 2	870.1025	2023-11-07
MXD	Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection)	Cardiovascular	Class 2	870.1025	2024-04-24
MXD	Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection)	Cardiovascular	Class 2	870.1025	2020-07-08
DTB	Permanent Pacemaker Electrode	Cardiovascular	Class 3	870.3680	2008-03-12
NVN	Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes	Unknown	Class 3	N/A	2008-03-12
NVY	Permanent Defibrillator Electrodes	Unknown	Class 3	N/A	2008-03-12
MXD	Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection)	Cardiovascular	Class 2	870.1025	2024-05-31
MXD	Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection)	Cardiovascular	Class 2	870.1025	2021-07-22
MXD	Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection)	Cardiovascular	Class 2	870.1025	2021-06-04
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
LWP	Implantable Pulse Generator, Pacemaker (Non-Crt)	Unknown	Class 3	N/A	2011-02-10
NVN	Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes	Unknown	Class 3	N/A	2011-02-10
NVZ	Pulse Generator, Permanent, Implantable	Unknown	Class 3	N/A	2011-02-10

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

Registration Number	Establishment Name	Location
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
K915007	Oscor Medical Corp.	PERMANENT PACING LEADS, MODIFICATION	1992-01-27
K253516	ABBOTT MEDICAL	Assert-IQ (DM5100)	2025-12-18
K891148	Del Mar Avionics	MODEL 152 DELTA HOLTER ECG ANALYSIS SYSTEM	1989-05-11

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0022-2016	Medtronic Inc. Cardiac Rhythm Disease Management	3	Medtronic Medical Device Identification Card for SureScan pacemaker patients. The front of this card identifies the implanted pacing system components currently registered to the patient. The back of the card lists patient's following physician as well as specific messaging regarding the MR conditional status of the device components, where applicable. This card is provided to the patient by Medtronic after device registration.
Z-0007-2025	Philips North America	2	IntelliVue G7m Anesthesia Gas Module, Product Number 866173
Z-0030-05	General Electric Medical Systems Information Technology	2	GE CIC Central Station Monitoring Product, Versions 3.x, 4.0.5, 4.0.6
Z-0034-2011	Philips Medical Systems North America Co. Phillips	2	The device's marketing brochure states: "IntelliVue M3150 Information Center...Philips Medical Systems". The beige-colored PAS-210 external speakers can be identified by their use of DB15-to-3.5 mm mini-phone jack cable (Agispec-081Y-4 or Agispec-081-6) to connect to the rp5700 PC. Indicated for central monitoring of multiple adult, pediatric, and neonatal patients.
Z-0035-2025	Philips North America	2	Patient Information Center iX, Product Code 866386, and Patient Information Center iX Expand, Product Code 866390, Software Revision 4.0.1

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008973940. Last updated year: 2026. Please use registration number 3008973940 when referencing this establishment in official correspondence.