Medtronic Model 53401 External Pulse Generator (EPG)

Medtronic Model 53401 External Pulse Generator (EPG) is an FDA 510(k)-cleared medical device (K180873) 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 April 18, 2018. Regulation: 8.