UNIPOLAR PEDIATRIC TEMPORARY PACING LEAD, UNIPOLAR TEMPORARY ATRIAL PACING LEAD, UNIPOLAR TEMPORARY MYOCARDIAL PACING

Electrode, Pacemaker, Temporary

MEDTRONIC, INC.

The following data is part of a premarket notification filed by Medtronic, Inc. with the FDA for Unipolar Pediatric Temporary Pacing Lead, Unipolar Temporary Atrial Pacing Lead, Unipolar Temporary Myocardial Pacing.

Pre-market Notification Details

Device IDK140972
510k NumberK140972
Device Name:UNIPOLAR PEDIATRIC TEMPORARY PACING LEAD, UNIPOLAR TEMPORARY ATRIAL PACING LEAD, UNIPOLAR TEMPORARY MYOCARDIAL PACING
ClassificationElectrode, Pacemaker, Temporary
Applicant MEDTRONIC, INC. 1851 EAST DEERE AVE. Santa Ana,  CA  92705
ContactDebra Taitague
CorrespondentDebra Taitague
MEDTRONIC, INC. 1851 EAST DEERE AVE. Santa Ana,  CA  92705
Product CodeLDF  
CFR Regulation Number870.3680 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-04-16
Decision Date2014-06-06
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
20643169310111 K140972 000
20643169310104 K140972 000
20643169310098 K140972 000
20643169310081 K140972 000
20643169310074 K140972 000

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