Data / Medical devices / Leadless Pacemaker / United States
FDA-registered makers of Leadless Pacemaker in the United States: 6 establishments
6 establishments in the United States are registered with the FDA to make Leadless Pacemaker (product code PNJ). 5 have a 510(k) clearance or PMA approval on file and 2 have a recall event. FDA data exported November 2, 2026.
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- Device
- Leadless Pacemaker
- Product code
- PNJ
- Country
- United States
Makers of Leadless Pacemaker in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Abbott Medical | Minnetonka, MN, United States | Manufacturer | 0 | 1 | 0 | 0 | api.fda.gov | |
| Abbott Medical | Sylmar, CA, United States | Manufacturer | 0 | 1 | 4 | 0 | api.fda.gov | |
| Abbott Medical | Arecibo, PR, United States | Manufacturer | 0 | 1 | 0 | 0 | api.fda.gov | |
| Medtronic Sofamor Danek Usa, Inc. | Memphis, TN, United States | Manufacturer | 0 | 1 | 0 | 0 | api.fda.gov | |
| Medtronic, Inc. | Mounds View, MN, United States | Manufacturer | 0 | 1 | 1 | 0 | api.fda.gov | |
| Benchmark Electronics, Inc. | Winona, MN, 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.