Data / Medical devices / Pacemaker Lead Adaptor
Pacemaker Lead Adaptor (DTD): 9 FDA-registered makers in 3 countries
9 establishments in 3 countries are registered with the FDA to make Pacemaker Lead Adaptor (product code DTD, Class 2, 21 CFR 870.3620). 7 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 103 510(k) clearances under this code, the latest on March 19, 2015, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- DTD
- Device class
- 2
- Regulation
- 870.3620
- Medical specialty
- Cardiovascular
- Implant
- Yes
Makers by country
| Country | Makers |
|---|---|
| United States | 7 |
| Germany | 1 |
| Dominican Republic | 1 |
Makers of Pacemaker Lead Adaptor
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 |
|---|---|---|---|---|---|---|---|---|
| Oscor Inc. | Palm Harbor, FL, United States | Complaint file establishment, Manufacturer | 5 | March 19, 2015 | 0 | 0 | 0 | api.fda.gov |
| Biotronik Se & Co. KG | Berlin, Germany | Manufacturer | 3 | January 18, 2001 | 0 | 0 | 0 | api.fda.gov |
| Medtronic, Inc. | Mounds View, MN, United States | Manufacturer, Specification developer | 3 | February 23, 2000 | 0 | 0 | 0 | api.fda.gov |
| Abbott Medical | Sylmar, CA, United States | Manufacturer | 2 | April 6, 1995 | 0 | 0 | 0 | api.fda.gov |
| Medtronic Puerto Rico Operations Co., Villalba | Villalba, PR, United States | Manufacturer | 2 | April 18, 1991 | 0 | 0 | 0 | api.fda.gov |
| Boston Scientific Corporation | Saint Paul, MN, United States | Complaint file establishment, Manufacturer, Specification developer | 1 | September 20, 1984 | 0 | 0 | 0 | api.fda.gov |
| Greatbatch Medical | Minneapolis, MN, United States | Manufacturer | 1 | March 3, 1987 | 0 | 0 | 0 | api.fda.gov |
| Heraeus Medical Components Caribe, Inc. | Dorado, PR, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Oscor Caribe LLC | SANTO DOMINGO Distrito Nacional, Dominican Republic | Contract manufacturer, Contract sterilizer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated March 19, 2015. 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.