Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3014918977

FEI Number

3014918977

Entity Name

Abbott Medical Costa Rica Limitada (Structural Heart)

City/State/Country

El Coyol Alajuela, CR

Establishment Address

Edificio #44 Calle 0, Ave. 2, Zona Franca Coyol, El Coyol Alajuela 20113, CR

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

Amplatzer Cardiac Plug (ACP) Amplatzer Duct Occluder Amplatzer Duct Occluder II Amplatzer Piccolo Occluder Amplatzer Cardiac Plug Amplatzer Amulet Left Atrial Appendage Occluder Tendyne Retrieval System Tendyne Delivery System Tendyne Stand Components Tendyne Apical Pad Tendyne Stand Tendyne Mitral Valve Tendyne Weight Tendyne Pad Positioning System Tendyne Loading System Navitor Loading System FlexNav Delivery System FlexNav Loading System Navitor Transcatheter Aortic Valve Navitor Titan Transcatheter Aortic Valve Navitor Loading System - LG+ Portico Transcatheter Aortic Valve 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
MAE	Occluder, Patent Ductus, Arteriosus	Unknown	Class 3	N/A	2017-02-17
MLV	Transcatheter Septal Occluder	Unknown	Class 3	N/A	2007-12-18
NPT	Aortic Valve, Prosthesis, Percutaneously Delivered	Unknown	Class 3	N/A	2013-02-26
NPU	Prosthesis, Mitral Valve, Percutaneously Delivered	Unknown	Class 3	N/A	2025-05-27
MAE	Occluder, Patent Ductus, Arteriosus	Unknown	Class 3	N/A	2015-09-11
MLV	Transcatheter Septal Occluder	Unknown	Class 3	N/A	2015-09-11
NPT	Aortic Valve, Prosthesis, Percutaneously Delivered	Unknown	Class 3	N/A	2021-09-17
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
3001883144	St. Jude Medical Brasil Ltda.	Belo Horizonte Minas Gerais, BR

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0491-2025	Abbott Medical	3	Abbott Navitor Titan, Vision Technology, Transcatheter Aortic Heart Valve, 35 mm, NVRO-35, Sterile
Z-0492-2025	Abbott Medical	3	Abbott Navitor Transcatheter Aortic Heart Valve, 29 mm, NVTR-29, Sterile
Z-0493-2025	Abbott Medical	3	Abbot Navitor, Vision Technology, Transcatheter Aortic Heart Valve, 29 mm, NVRO-29, Sterile
Z-0494-2025	Abbott Medical	3	Abbott Navitor, Vision Technology, Transcatheter Aortic Heart Valve, 27 mm, NVRO-27, Sterile
Z-0495-2025	Abbott Medical	3	Abbott Navitor Transcatheter Aortic Heart Valve, 27 mm, NVTR-27, Sterile

Similar Registrations

Registration Number	Establishment Name	Location
3007113487	Abbott Medical	Saint Paul, MN, US
3026560514	PFM MEDICAL MSG GMBH	Nonnweiler Saarland, DE
1928237	MIDWEST STERILIZATION CORP.	JACKSON, MO, US
3012179728	St. Jude Medical	Roseville, MN, US
2135147	Abbott Medical	Plymouth, MN, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014918977. Last updated year: 2026. Please use registration number 3014918977 when referencing this establishment in official correspondence.