MEDTRONIC 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 External Pulse Generator (epg).

Pre-market Notification Details

Device IDK132924
510k NumberK132924
Device Name:MEDTRONIC EXTERNAL PULSE GENERATOR (EPG)
ClassificationPulse-generator, Pacemaker, External
Applicant MEDTRONIC, INC. 8200 Coral Sea Street NE Mounds View,  MN  55112
ContactEric Kalmes
CorrespondentEric Kalmes
MEDTRONIC, INC. 8200 Coral Sea Street NE Mounds View,  MN  55112
Product CodeDTE  
CFR Regulation Number870.3600 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-09-18
Decision Date2013-10-31

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00643169508767 K132924 000
00643169305120 K132924 000
00643169230859 K132924 000

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