Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9611350

FEI Number

1000241540

Entity Name

MEDTRONIC FABRICATION S.A.S.

City/State/Country

FOURMIES Nord, FR

Establishment Address

103 ROUTE D ANOR, FOURMIES Nord 59610, FR

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

K973360

PMA Number

N/A

All Registered Proprietary Names

Streamline Temporary Pacing Leads Streamline Temporary Pacing Wire Streamline Temporary Pacing Leads Temporary Pacing Lead System, Model 6416

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LDF	Electrode, Pacemaker, Temporary	Cardiovascular	Class 2	870.3680	2017-11-01
LDF	Electrode, Pacemaker, Temporary	Cardiovascular	Class 2	870.3680	2019-10-04
LDF	Electrode, Pacemaker, Temporary	Cardiovascular	Class 2	870.3680	2009-02-04

Official Correspondent

No official correspondent registered.

US Agent Details

Ryan Calabrese Business: MEDTRONIC Email: ryan.s.calabrese@medtronic.com Phone: (763) 5263515

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

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2024168	ABBOTT VASCULAR	Temecula, CA, US
3006082230	C.R. BARD, INC.	MADISON, GA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9611350. Last updated year: 2026. Please use registration number 9611350 when referencing this establishment in official correspondence.