Data / Medical devices / Costa Rica / Abbott Medical Costa Rica Limitada (Structural Heart)

Abbott Medical Costa Rica Limitada (Structural Heart): FDA-registered device maker in El Coyol Alajuela, Costa Rica, 6 PMA approvals

Name: Abbott Medical Costa Rica Limitada (Structural Heart) FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Abbott Medical Costa Rica Limitada (Structural Heart) is registered with the FDA (registration 3014918977) in El Coyol Alajuela, Costa Rica. It lists 9 device types. The FDA files 6 PMA approvals under its listings, the newest dated May 23, 2025. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3014918977
Address: Edificio #44 Calle 0, Ave. 2 Zona Franca Coyol, El Coyol Alajuela, Costa Rica, 20113
Owner or operator: ABBOTT LABORATORIES (1415939)
Roles: Manufacturer
First device listed: May 14, 1996
Registered through: 2026
Brand names listed: Amplatzer Amulet Left Atrial Appendage Occluder, Amplatzer Cardiac Plug, Amplatzer Piccolo Occluder, Amplatzer Amulet Left Atrial Appendage Occluder, Amplatzer Cardiac Plug (ACP), Amplatzer Duct Occluder, Amplatzer Duct Occluder II, Double-ended Handle Sizer Rings (15mm MHV Sizer) and more

Devices it lists

Device	Product code	Class	Role	Source
Aortic Valve, Prosthesis, Percutaneously Delivered	NPT	3	Manufacturer	accessdata.fda.gov
Heart-Valve, Mechanical	LWQ	3	Manufacturer	accessdata.fda.gov
Heart-Valve, Non-Allograft Tissue	LWR	3	Manufacturer	accessdata.fda.gov
Occluder, Patent Ductus, Arteriosus	MAE	3	Manufacturer	accessdata.fda.gov
Prosthesis, Mitral Valve, Percutaneously Delivered	NPU	3	Manufacturer	accessdata.fda.gov
Replacement Heart-Valve	DYE	3	Manufacturer	accessdata.fda.gov
Sizer, Heart-Valve, Prosthesis	DTI	1	Manufacturer	accessdata.fda.gov
System, Appendage Closure, Left Atrial	NGV	3	Manufacturer	accessdata.fda.gov
Transcatheter Septal Occluder	MLV	3	Manufacturer	accessdata.fda.gov

PMA approvals

Premarket approvals this establishment lists, with the supplements the FDA has decided since.

Approved	PMA number	Device	Product code	Supplements	Latest decision	Source
May 23, 2025	P240042	Tendyne Transcatheter Mitral Valve System	NPU	4	August 31, 2026	accessdata.fda.gov
September 17, 2021	P190023	Portico Transcatheter Aortic Valve Implantation System	NPT	32	July 9, 2026	accessdata.fda.gov
August 14, 2021	P200049	Amplatzer Amulet Left Atrial Appendage Occluder	NGV	19	August 28, 2026	accessdata.fda.gov
August 5, 2005	P040021	SJM BIOCOR VALVE / SJM BIOCOR SUPRA VALVE	LWR	60	September 18, 2026	accessdata.fda.gov
May 14, 2003	P020024	AMPLATZER DUCT OCCLUDER AND 180 DEGREE DELIVERY SYSTEM	MAE	65	May 28, 2026	accessdata.fda.gov
December 5, 2001	P000039	THE AMPLATZER(R) SEPTAL OCCLUDER (ASO) AND THE AMPLATZER EXCHANGE SYSTEM	MLV	76	May 28, 2026	accessdata.fda.gov

Compare with other makers

Updated August 31, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.