Data / Medical devices / Analyzer, Pacemaker Generator Function
Analyzer, Pacemaker Generator Function (DTC): 5 FDA-registered makers in 3 countries
5 establishments in 3 countries are registered with the FDA to make Analyzer, Pacemaker Generator Function (product code DTC, Class 2, 21 CFR 870.3630). 3 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 30 510(k) clearances under this code, the latest on July 6, 2017, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- DTC
- Device class
- 2
- Regulation
- 870.3630
- Medical specialty
- Cardiovascular
Makers by country
| Country | Makers |
|---|---|
| United States | 3 |
| Germany | 1 |
| China | 1 |
Makers of Analyzer, Pacemaker Generator 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 |
|---|---|---|---|---|---|---|---|---|
| Biotronik Se & Co. KG | Berlin, Germany | Manufacturer | 1 | April 1, 2009 | 0 | 0 | 0 | api.fda.gov |
| Boston Scientific Corporation | Saint Paul, MN, United States | Specification developer | 1 | July 6, 2017 | 0 | 0 | 0 | api.fda.gov |
| Netech Corp. | E Farmingdale, NY, United States | Manufacturer | 1 | November 8, 1996 | 0 | 0 | 0 | api.fda.gov |
| Amphenol Alden Products Company | Shenzhen Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medtronic, Inc. | Mounds View, MN, United States | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated July 6, 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.