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 IDK181973
510k NumberK181973
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 Received2018-07-24
Decision Date2018-08-21
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00763000162443 K181973 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.