Medtronic Model 5392 External Pulse Generator (EPG)

Pulse-generator, Pacemaker, External

Medtronic, Inc.

The following data is part of a premarket notification filed by Medtronic, Inc. with the FDA for Medtronic Model 5392 External Pulse Generator (epg).

Pre-market Notification Details

Device IDK201011
510k NumberK201011
Device Name:Medtronic Model 5392 External Pulse Generator (EPG)
ClassificationPulse-generator, Pacemaker, External
Applicant Medtronic, Inc. 8200 Coral Sea Street N.E. Mounds View,  MN  55112
ContactAlexandra Theisen
CorrespondentAlexandra Theisen
Medtronic, Inc. 8200 Coral Sea Street N.E. Mounds View,  MN  55112
Product CodeDTE  
CFR Regulation Number870.3600 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-04-17
Decision Date2020-05-13

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