Data / Medical devices / Generator, Pulse, Pacemaker, External Programmable (For Electrophysiological Studies Only)
Generator, Pulse, Pacemaker, External Programmable (For Electrophysiological Studies Only) (JOQ): 5 FDA-registered makers in 2 countries
5 establishments in 2 countries are registered with the FDA to make Generator, Pulse, Pacemaker, External Programmable (For Electrophysiological Studies Only) (product code JOQ, Class 2, 21 CFR 870.1750). 5 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 18 510(k) clearances under this code, the latest on March 29, 2018, and lists 3 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- JOQ
- Device class
- 2
- Regulation
- 870.1750
- Medical specialty
- Cardiovascular
- Life sustaining or supporting
- Yes
Makers by country
| Country | Makers |
|---|---|
| United States | 4 |
| Australia | 1 |
Makers of Generator, Pulse, Pacemaker, External Programmable (For Electrophysiological Studies Only)
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, Inc. | Mounds View, MN, United States | Manufacturer, Repackager or relabeler, Specification developer | 4 | August 4, 1986 | 0 | 0 | 0 | api.fda.gov |
| Fischer Medical | Wheat Ridge, CO, United States | Manufacturer, Remanufacturer | 2 | March 29, 2018 | 0 | 0 | 0 | api.fda.gov |
| Micropace Pty. Ltd. | Homebush West New South Wales, Australia | Manufacturer | 2 | October 26, 2007 | 0 | 0 | 0 | api.fda.gov |
| St. Jude Medical | Roseville, MN, United States | Manufacturer | 1 | October 16, 2009 | 0 | 0 | 0 | api.fda.gov |
| St. Jude Medical, Atrial Fibrillation Division, Inc. | Saint Paul, MN, United States | Manufacturer, Specification developer | 1 | October 16, 2009 | 0 | 0 | 0 | api.fda.gov |
Updated March 29, 2018. 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.