Edwards Pacemaker Systems
Country not established
- Devices
- 13
What Edwards Pacemaker Systems makes
The company manufactures unipolar and bipolar cardiac pulse generators, including single- and dual-chamber pacemakers like the MICROPULSE 26U, PROLITH 23S, and 28U models. Their portfolio also includes lead conversion kits and pacemaker system analyzers, such as the PSA-5. Devices are designed for cardiac rhythm management, with pulse generators ranging from 20U to 30U models.
These devices are classified under FDA Class II and Class III regulations, with most entries supported by 510(k) clearance. The products are listed in the FDA’s 510(k) registry, reflecting their regulatory authorization status. The company is based in the United States.
Catalogue
Search and filter all 13 devicesFrequently asked questions
How many devices does Edwards Pacemaker Systems have in the registry?
The registry currently lists 13 devices for Edwards Pacemaker Systems. Devices recorded under merged duplicate company entries are counted once.
Which registries list Edwards Pacemaker Systems's devices?
Among its 13 most recently registered devices, Edwards Pacemaker Systems has devices listed in FDA 510(k) (13 devices).
What risk classes do Edwards Pacemaker Systems's devices fall under?
Among its 13 most recently registered devices, the classes recorded for Edwards Pacemaker Systems's devices are Class II and Class III. Each device page shows its own class and authorisation.
What are the newest devices from Edwards Pacemaker Systems in the registry?
The most recently registered devices listed for Edwards Pacemaker Systems include MICROPULSE 26U PULSE GENERATOR, EDWARDS PACEMAKER 30 UNIPOLAR GENERATOR, MICROPULSE 22S PACEMAKER and PROLITH 23S PACEMAKER.