Medtronic Model 5392 External Pulse Generator (EPG)

Medtronic Model 5392 External Pulse Generator (EPG) is an FDA 510(k)-cleared medical device (K201011) manufactured by Medtronic, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 12, 2020. Regulation: 8.