Data / Medical devices / Permanent Pacemaker Electrode

Permanent Pacemaker Electrode (DTB): 16 FDA-registered makers in 5 countries

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

16 establishments in 5 countries are registered with the FDA to make Permanent Pacemaker Electrode (product code DTB, Class 3, 21 CFR 870.3680). 4 of them have a 510(k) clearance or PMA approval on file and 3 have a recall event. The FDA has issued 487 510(k) clearances under this code, the latest on July 10, 2006, and lists 6 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code: DTB
Device class: 3
Regulation: 870.3680
Medical specialty: Cardiovascular
Implant: Yes

Makers by country

Country	Makers
United States	11
Singapore	2
Malaysia	1
Germany	1
Ireland	1

Makers of Permanent Pacemaker Electrode

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	510(k) clearances	Latest clearance	PMA approvals	Recall events	Source
Oscor Inc.	Palm Harbor, FL, United States	Complaint file establishment, Contract sterilizer, Manufacturer	6	August 6, 2004	0	1	api.fda.gov
Medtronic Puerto Rico Operations Co., Villalba	Villalba, PR, United States	Manufacturer, Manufacturer for export	2	May 22, 2003	1	0	api.fda.gov
Greatbatch Medical	Minneapolis, MN, United States	Manufacturer	0		1	3	api.fda.gov
Medtronic, Inc.	Mounds View, MN, United States	Manufacturer, Specification developer	1	December 1, 1980	0	2	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 Apm Ii Pte. Ltd	Singapore South East, Singapore	Contract manufacturer	0		0	0	api.fda.gov
Biotronik Se & Co. KG	Berlin, Germany	Manufacturer	0		0	0	api.fda.gov
Boston Scientific Corporation	Saint Paul, MN, United States	Complaint file establishment, Manufacturer, Specification developer	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
Heraeus Medical Components, LLC	Saint Paul, MN, United States	Contract manufacturer	0		0	0	api.fda.gov
Heraeus Medical Components Caribe, Inc.	Dorado, PR, United States	Contract 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
Pro-Tech Design & MFG., Inc.	Santa Fe Springs, CA, United States	Contract manufacturer	0		0	0	api.fda.gov

Updated July 10, 2006. 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.