Data / Medical devices / Implantable Pacemaker Pulse-Generator
Implantable Pacemaker Pulse-Generator (DXY): 20 FDA-registered makers in 8 countries
20 establishments in 8 countries are registered with the FDA to make Implantable Pacemaker Pulse-Generator (product code DXY, Class 3, 21 CFR 870.3610). 6 of them have a 510(k) clearance or PMA approval on file and 3 have a recall event. The FDA has issued 461 510(k) clearances under this code, the latest on November 10, 1999, and lists 16 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- DXY
- Device class
- 3
- Regulation
- 870.3610
- Medical specialty
- Cardiovascular
- Implant
- Yes
Makers by country
| Country | Makers |
|---|---|
| United States | 11 |
| Malaysia | 2 |
| Singapore | 2 |
| Germany | 1 |
| Italy | 1 |
| France | 1 |
| Switzerland | 1 |
| Taiwan | 1 |
Makers of Implantable Pacemaker Pulse-Generator
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 |
|---|---|---|---|---|---|---|---|---|
| Abbott Medical | Sylmar, CA, United States | Complaint file establishment, Manufacturer | 0 | 2 | 6 | 0 | api.fda.gov | |
| Abbott Medical | Arecibo, PR, United States | Manufacturer | 0 | 2 | 0 | 0 | api.fda.gov | |
| Abbott Medical | Penang Pulau Pinang, Malaysia | Manufacturer | 0 | 1 | 0 | 0 | api.fda.gov | |
| Biotronik Se & Co. KG | Berlin, Germany | Manufacturer | 0 | 1 | 0 | 0 | api.fda.gov | |
| MicroPort CRM S.r.l. | Saluggia (VC) Vercelli, Italy | Manufacturer, Repackager or relabeler | 0 | 1 | 0 | 0 | api.fda.gov | |
| Sorin CRM SAS | CLAMART Hauts-de-Seine, France | Complaint file establishment, Repackager or relabeler, Specification developer | 0 | 1 | 0 | 0 | api.fda.gov | |
| Benchmark Electronics, Inc. | Winona, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Biotronik Apm Ii Pte. Ltd | Singapore South East, Singapore | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Boston Scientific Corporation | Saint Paul, MN, United States | Complaint file establishment, Manufacturer, Specification developer | 0 | 0 | 4 | 0 | api.fda.gov | |
| Boston Scientific Corporation | Dorado, PR, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medtronic Puerto Rico Operations Co., Juncos | Juncos, PR, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medtronic Puerto Rico Operations Co., Villalba | Villalba, PR, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medtronic Sofamor Danek Usa, Inc. | Memphis, TN, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medtronic, Inc. | Mounds View, MN, United States | Manufacturer, Repackager or relabeler, Specification developer | 0 | 0 | 3 | 0 | api.fda.gov | |
| Medtronic Europe Sarl | TOLOCHENAZ Vaud, Switzerland | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medtronic Singapore Operations Pte Ltd | Singapore Central Singapore, Singapore | Manufacturer | 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 | |
| Plexus Manufacturing Sdn. Bhd. | Bayan Lepas Pulau Pinang, Malaysia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Technical Services For Electronics, Inc. | Jackson, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Technical Services for Electronics, Inc. | New Taipei City, Taiwan | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 10, 1999. 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.