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 IDK150246
510k NumberK150246
Device Name:Medtronic Model 5392 External Pulse Generator (EPG)
ClassificationPulse-generator, Pacemaker, External
Applicant Medtronic, Inc 8200 Coral Sea Street NE Mounds View,  MN  55112
ContactBecky Severson
CorrespondentBecky Severson
Medtronic, Inc 8200 Coral Sea Street NE Mounds View,  MN  55112
Product CodeDTE  
CFR Regulation Number870.3600 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-02-02
Decision Date2015-02-18
Summary:summary

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