# Edwards Pacemaker Systems

- Location (FDA's records): Mchenry, IL
- FDA decisions: 13 (1977–1979): 13 510(k) clearances
- Product codes: DXY (11), DTC (1)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 0 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Recent decisions
- K791751: Edwards Pacemaker 30 Unipolar Generator (Sep 26, 1979)
- K790452: 28 Unipolar and Bipolar Pulse Generators (May 8, 1979)
- K781111: Lead Conversion Kit, Model 341 (Aug 31, 1978)
- K781144: Analyzer, Pacer System, Psa-5 (Aug 23, 1978)
- K781042: Prolith 23S Pacemaker (Jul 27, 1978)
- K780780: Micropulse 22S Pacemaker (Jun 30, 1978)
- K780238: Pacemaker, Prolith 23U. Pulse Generator (Mar 15, 1978)
- K780091: Micropulse 22U (Jan 30, 1978)

Source page: https://510kreport.com/company/edwards-pacemaker-systems