Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3001883144

FEI Number

3001883144

Entity Name

St. Jude Medical Brasil Ltda.

City/State/Country

Belo Horizonte Minas Gerais, BR

Establishment Address

Rua Professor José Vieira de Mendonça, 1301, Bairro Engenho Nogueira, Belo Horizonte Minas Gerais 31.310-260, BR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

ABBOTT LABORATORIES (Owner Number: 1415939)

Owner / Operator Contact Address

100 ABBOTT PARK RD., D-03Q3, AP52-1, Abbott Park, IL 60064, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

P040021

All Registered Proprietary Names

Epic Supra Valve (Aortic) Epic Plus Supra Valve (Aortic) Epic Plus Valve (Mitral) Epic Plus Valve (Aortic) Epic Valve (Mitral) Epic Max Valve (Aortic) Epic Valve (Aortic)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LWQ	Heart-Valve, Mechanical	Unknown	Class 3	N/A	2007-10-16
LWR	Heart-Valve, Non-Allograft Tissue	Unknown	Class 3	N/A	2007-10-16
DYE	Replacement Heart-Valve	Cardiovascular	Class 3	870.3925	2007-10-16

Official Correspondent

No official correspondent registered.

US Agent Details

Alessandra Chaves Business: Alessandra Chaves Sr Manager Structural Heart Email: alessandra.chavesmora@abbott.com Phone: (651) 9555337

Related Public Records

Same Entity

ABBOTT LABORATORIES

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3004032053	Abbott S.r.l.	Milan Lombardy, IT
3011706799	Abbott Medical	Atlanta, GA, US
1628664	ABBOTT LABORATORIES	IRVING, TX, US
3023268435	Abbott Automation Solutions GmbH	Hamburg, DE
3038966633	Abbott Medical Mexico, S. de R.L. de C.V.	Santa Rosa Jauregui Queretaro, MX

Similar Registrations

Registration Number	Establishment Name	Location
9612515	VASCUTEK LTD.	Inchinnan Renfrewshire, GB
3010432890	Sterigenics Costa Rica S.R.L.	El Coyol Alajuela, CR
2135147	Abbott Medical	Plymouth, MN, US
3007113487	Abbott Medical	Saint Paul, MN, US
1063481	Artivion, Inc.	Kennesaw, GA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3001883144. Last updated year: 2026. Please use registration number 3001883144 when referencing this establishment in official correspondence.