Data / Medical devices / Permanent Pacemaker Electrode / United States
FDA-registered makers of Permanent Pacemaker Electrode in the United States: 11 establishments
11 establishments in the United States are registered with the FDA to make Permanent Pacemaker Electrode (product code DTB). 4 have a 510(k) clearance or PMA approval on file and 3 have a recall event. FDA data exported November 2, 2026.
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- Device
- Permanent Pacemaker Electrode
- Product code
- DTB
- Country
- United States
Makers of Permanent Pacemaker Electrode in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Oscor Inc. | Palm Harbor, FL, United States | Complaint file establishment, Contract sterilizer, Manufacturer | 6 | August 6, 2004 | 0 | 1 | 0 | api.fda.gov |
| Medtronic Puerto Rico Operations Co., Villalba | Villalba, PR, United States | Manufacturer, Manufacturer for export | 2 | May 22, 2003 | 1 | 0 | 0 | api.fda.gov |
| Greatbatch Medical | Minneapolis, MN, United States | Manufacturer | 0 | 1 | 3 | 0 | api.fda.gov | |
| Medtronic, Inc. | Mounds View, MN, United States | Manufacturer, Specification developer | 1 | December 1, 1980 | 0 | 2 | 0 | api.fda.gov |
| Abbott Medical | Sylmar, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Abbott Medical | Arecibo, PR, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Boston Scientific Corporation | Saint Paul, MN, United States | Complaint file establishment, Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Boston Scientific Corporation | Dorado, PR, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Heraeus Medical Components, LLC | Saint Paul, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Heraeus Medical Components Caribe, Inc. | Dorado, PR, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Pro-Tech Design & MFG., Inc. | Santa Fe Springs, CA, United States | Contract manufacturer | 0 | 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.