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 IDK162550
510k NumberK162550
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
ContactBrenna Loufek
CorrespondentBrenna Loufek
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 Received2016-09-13
Decision Date2016-10-12
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00643169725126 K162550 000

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