Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015544746

FEI Number

3015544746

Entity Name

Medtronic, Inc.

City/State/Country

Minneapolis, MN, US

Establishment Address

7000 Central Ave., N.E., Minneapolis, MN 55432, US

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

K150246

PMA Number

N/A

All Registered Proprietary Names

External Pulse Generator EPG Cover External Pulse Generator External Pacemaker Pulse Generator TYRX Neuro Absorbable Antibacterial Envelope LINQ Tool Kit LINQ II Insertable Cardiac Monitor Medtronic Temporary External Pacemaker TYRX Absorbable Antibacterial Envelope TYRX Absorbable Antibacterial Envelope Reveal LINQ Insertion Tools REVEAL LINQ TYRX Absorbable Antibacterial Envelope External Pulse Generator TYRX Absorbable Antibacterial Envelope External Pulse Generator EPG Cover

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DTE	Pulse-Generator, Pacemaker, External	Cardiovascular	Class 2	870.3600	2019-07-03
DTE	Pulse-Generator, Pacemaker, External	Cardiovascular	Class 2	870.3600	2017-01-19
DTE	Pulse-Generator, Pacemaker, External	Cardiovascular	Class 2	870.3600	2013-12-05
FTL	Mesh, Surgical, Polymeric	General, Plastic Surgery	Class 2	878.3300	2021-04-05
MXD	Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection)	Cardiovascular	Class 2	870.1025	2020-07-08
DTE	Pulse-Generator, Pacemaker, External	Cardiovascular	Class 2	870.3600	2018-09-07
FTL	Mesh, Surgical, Polymeric	General, Plastic Surgery	Class 2	878.3300	2019-04-02
FTL	Mesh, Surgical, Polymeric	General, Plastic Surgery	Class 2	878.3300	2021-01-11
MXD	Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection)	Cardiovascular	Class 2	870.1025	2014-02-18
FTL	Mesh, Surgical, Polymeric	General, Plastic Surgery	Class 2	878.3300	2018-06-13
DTE	Pulse-Generator, Pacemaker, External	Cardiovascular	Class 2	870.3600	2018-09-13
FTL	Mesh, Surgical, Polymeric	General, Plastic Surgery	Class 2	878.3300	2018-04-25
DTE	Pulse-Generator, Pacemaker, External	Cardiovascular	Class 2	870.3600	2015-03-02

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

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
K220540	Covidien	ProGrip Self-Gripping Polypropylene Mesh	2022-09-22
K253516	ABBOTT MEDICAL	Assert-IQ (DM5100)	2025-12-18

Similar Registrations

Registration Number	Establishment Name	Location
9681449	OSYPKA MEDICAL GMBH	BERLIN, DE
3004593495	Plexus Manufacturing Sdn. Bhd.	Bayan Lepas Pulau Pinang, MY
2182208	MEDTRONIC, INC.	Mounds View, MN, US
1028232	BIOTRONIK, INC.	LAKE OSWEGO, OR, US
3018094310	Medtronic Engineering and Innovation Center (MEIC)	Hyderabad Telangana, IN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015544746. Last updated year: 2026. Please use registration number 3015544746 when referencing this establishment in official correspondence.