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Edwards Lifesciences Ireland Limited: FDA-registered device maker in Limerick Munster, Ireland, 1 510(k) clearance and 3 PMA approvals

Name: Edwards Lifesciences Ireland Limited FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Edwards Lifesciences Ireland Limited is registered with the FDA (registration 3017298588) in Limerick Munster, Ireland. It lists 7 device types. The FDA files 1 510(k) clearance and 3 PMA approvals under its listings, the newest dated September 14, 2022. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number: 3017298588
Address: National Technology Park Castletroy, Limerick Munster, Ireland, V94 31X5
Owner or operator: Edwards Lifesciences LLC (9040666)
Roles: Manufacturer
First device listed: June 22, 2015
Registered through: 2027
Brand names listed: Edwards COMMANDER Delivery System, Edwards Certitude Delivery System, Edwards Certitude Introducer Sheath, Edwards Certitude Introducer Sheath Set, Edwards Commander Delivery System, Edwards Crimper, Edwards EVOQUE Accessories, Edwards EVOQUE Stabilizer and more

Devices it lists

Device	Product code	Class	Role	Source
Aortic Valve, Prosthesis, Percutaneously Delivered	NPT	3	Manufacturer	accessdata.fda.gov
Cardiovascular Delivery Catheter System Positioning And Stabilization Device	QWA	1	Manufacturer	accessdata.fda.gov
Introducer, Catheter	DYB	2	Manufacturer	accessdata.fda.gov
Mitral Valve Repair Devices	NKM	3	Manufacturer	accessdata.fda.gov
Prosthesis, Mitral Valve, Percutaneously Delivered	NPU	3	Manufacturer	accessdata.fda.gov
Pulmonary Valve Prosthesis Percutaneously Delivered	NPV	f	Manufacturer	accessdata.fda.gov
Tricuspid Valve Repair Device, Percutaneously Delivered	NPS	3	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
March 9, 2020	K200258	Edwards eSheath Introducer Set	DYB	Substantially Equivalent	Edwards Lifesciences	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
September 14, 2022	P220003	PASCAL Precision Transcatheter Valve Repair System	NKM	33	October 22, 2026	accessdata.fda.gov
August 31, 2020	P200015	Edwards SAPIEN 3 Transcatheter Heart Valve System with Edwards Commander Delivery System	NPV	80	September 23, 2026	accessdata.fda.gov
June 17, 2015	P140031	SAPIEN 3 TRANSCATHETER HEART VALVE AND ACCESSORIES	NPT	202	October 22, 2026	accessdata.fda.gov

Compare with other makers

Updated October 22, 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.