Data / Medical devices / Tester, Pacemaker Electrode Function
Tester, Pacemaker Electrode Function (DTA): 7 FDA-registered makers in 3 countries
7 establishments in 3 countries are registered with the FDA to make Tester, Pacemaker Electrode Function (product code DTA, Class 2, 21 CFR 870.3720). 2 of them have a 510(k) clearance or PMA approval on file and 2 have a recall event. The FDA has issued 10 510(k) clearances under this code, the latest on February 28, 2017, and lists 2 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- DTA
- Device class
- 2
- Regulation
- 870.3720
- Medical specialty
- Cardiovascular
Makers by country
| Country | Makers |
|---|---|
| United States | 4 |
| Germany | 2 |
| Dominican Republic | 1 |
Makers of Tester, Pacemaker Electrode Function
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 | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Abbott Medical | Sylmar, CA, United States | Manufacturer | 1 | December 21, 2010 | 0 | 0 | 0 | api.fda.gov |
| Medtronic, Inc. | Mounds View, MN, United States | Manufacturer, Manufacturer for export, Specification developer | 1 | February 28, 2017 | 0 | 1 | 0 | api.fda.gov |
| Biotronik Se & Co. KG | Berlin, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Osypka Medical GMBH | Berlin, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Remington Medical, Inc. | Alpharetta, GA, United States | Contract manufacturer | 0 | 0 | 1 | 0 | api.fda.gov | |
| Remington Medical, S.A. | Santo Domingo Este, Dominican Republic | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Technical Services For Electronics, Inc. | Jackson, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated February 28, 2017. 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.