Data / Medical devices / Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode
Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode (OJX): 14 FDA-registered makers in 6 countries
14 establishments in 6 countries are registered with the FDA to make Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode (product code OJX, Class 3). 4 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 0 510(k) clearances under this code, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- OJX
- Device class
- 3
- Medical specialty
- Unknown
- Implant
- Yes
- Life sustaining or supporting
- Yes
Makers by country
| Country | Makers |
|---|---|
| United States | 9 |
| Malaysia | 1 |
| China | 1 |
| Germany | 1 |
| Ireland | 1 |
| Switzerland | 1 |
Makers of Drug Eluting Permanent Left Ventricular (Lv) 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 | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Medtronic Puerto Rico Operations Co., Villalba | Villalba, PR, United States | Manufacturer, Repackager or relabeler | 0 | 2 | 0 | 0 | api.fda.gov | |
| Boston Scientific Corporation | Saint Paul, MN, United States | Complaint file establishment, Manufacturer, Specification developer | 0 | 1 | 0 | 0 | api.fda.gov | |
| Boston Scientific Corporation | Dorado, PR, United States | Manufacturer | 0 | 1 | 0 | 0 | api.fda.gov | |
| Medtronic, Inc. | Mounds View, MN, United States | Manufacturer, Specification developer | 0 | 1 | 0 | 0 | api.fda.gov | |
| Abbott Medical | Sylmar, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Abbott Medical | Penang Pulau Pinang, Malaysia | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Abbott Medical | Arecibo, PR, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Amphenol Medical Technologies (Dongguan) Co., Ltd. | Dongguan Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Benchmark Electronics, Inc. | Winona, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Biotronik Se & Co. KG | Berlin, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Boston Scientific Limited | CLONMEL Tipperary, Ireland | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medtronic Vascular | Danvers, MA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medtronic Europe Sarl | TOLOCHENAZ Vaud, Switzerland | Manufacturer, Repackager or relabeler | 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.