Data / Medical devices / Permanent Defibrillator Electrodes

Permanent Defibrillator Electrodes (NVY): 23 FDA-registered makers in 8 countries

Name: FDA-registered makers of Permanent Defibrillator Electrodes
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

23 establishments in 8 countries are registered with the FDA to make Permanent Defibrillator Electrodes (product code NVY, Class 3). 4 of them have a 510(k) clearance or PMA approval on file and 2 have a recall event. The FDA has issued 0 510(k) clearances under this code, and lists 4 recall events (1 Class I). FDA data exported November 2, 2026.

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Product code: NVY
Device class: 3
Medical specialty: Unknown
Implant: Yes
Life sustaining or supporting: Yes

Makers by country

Country	Makers
United States	16
Netherlands	1
Malaysia	1
Germany	1
Ireland	1
Switzerland	1
Singapore	1
Mexico	1

Makers of Permanent Defibrillator Electrodes

Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.

Maker	Location	Role	PMA approvals	Recall events	Class I	Source
Medtronic Puerto Rico Operations Co., Villalba	Villalba, PR, United States	Manufacturer	2	0	0	api.fda.gov
Medtronic, Inc.	Mounds View, MN, United States	Manufacturer, Specification developer	2	2	0	api.fda.gov
Medtronic Sofamor Danek Usa, Inc.	Memphis, TN, United States	Manufacturer	1	0	0	api.fda.gov
Medtronic Bakken Research Center B.V. (BRC)	Maastricht Limburg, Netherlands	Manufacturer	1	0	0	api.fda.gov
Abbott Medical	Sylmar, CA, United States	Manufacturer	0	0	0	api.fda.gov
Abbott Medical	Penang Pulau Pinang, Malaysia	Manufacturer	0	0	0	api.fda.gov
Abbott Medical	Arecibo, PR, United States	Manufacturer	0	0	0	api.fda.gov
Biotronik Se & Co. KG	Berlin, Germany	Manufacturer	0	0	0	api.fda.gov
Boston Scientific Corporation	Spencer, IN, United States	Manufacturer	0	0	0	api.fda.gov
Boston Scientific Corp., Marina Bay Cust. Fulfillment Center	Quincy, MA, United States	Manufacturer	0	0	0	api.fda.gov
Boston Scientific Corporation	Saint Paul, MN, United States	Complaint file establishment, Manufacturer, Specification developer	0	2	1	api.fda.gov
Boston Scientific Corporation	Coventry, RI, United States	Manufacturer	0	0	0	api.fda.gov
Boston Scientific Corporation	Dorado, PR, United States	Manufacturer	0	0	0	api.fda.gov
Boston Scientific Limited	CLONMEL Tipperary, Ireland	Manufacturer	0	0	0	api.fda.gov
Donatelle Plastics, LLC	New Brighton, MN, United States	Contract manufacturer	0	0	0	api.fda.gov
Greatbatch Medical	Minneapolis, MN, United States	Contract manufacturer	0	0	0	api.fda.gov
JunoPacific, Inc.	Brooklyn Park, MN, United States	Contract manufacturer	0	0	0	api.fda.gov
Medtronic Europe Sarl	TOLOCHENAZ Vaud, Switzerland	Manufacturer	0	0	0	api.fda.gov
Medtronic Singapore Operations Pte Ltd	Singapore Central Singapore, Singapore	Manufacturer, Repackager or relabeler	0	0	0	api.fda.gov
Plexus Corp.	Buffalo Grove, IL, United States	Contract manufacturer	0	0	0	api.fda.gov
Pro-Tech Design & MFG., Inc.	Santa Fe Springs, CA, United States	Contract manufacturer	0	0	0	api.fda.gov
Plexus Electronica S. de R.L. de C.V..	Zapopan Jalisco, Mexico	Contract manufacturer	0	0	0	api.fda.gov
Trelleborg Sealing Solutions US, Inc	Delano, MN, United States	Contract manufacturer	0	0	0	api.fda.gov

Updated November 2, 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.