6981M LEAD EXTENDER KIT, 6984M LEAD EXTENDER KIT, 6986M LEAD EXTENDER KIT, 5866-24M LEAD ADAPTOR KIT, 5866-38M LEAD ADAP

Pacemaker Lead Adaptor

MEDTRONIC INC.

The following data is part of a premarket notification filed by Medtronic Inc. with the FDA for 6981m Lead Extender Kit, 6984m Lead Extender Kit, 6986m Lead Extender Kit, 5866-24m Lead Adaptor Kit, 5866-38m Lead Adap.

Pre-market Notification Details

Device IDK132008
510k NumberK132008
Device Name:6981M LEAD EXTENDER KIT, 6984M LEAD EXTENDER KIT, 6986M LEAD EXTENDER KIT, 5866-24M LEAD ADAPTOR KIT, 5866-38M LEAD ADAP
ClassificationPacemaker Lead Adaptor
Applicant MEDTRONIC INC. 8200 CORAL SEA STREET Mounds View,  MN  55112
ContactMichele Machacek
CorrespondentMichele Machacek
MEDTRONIC INC. 8200 CORAL SEA STREET Mounds View,  MN  55112
Product CodeDTD  
CFR Regulation Number870.3620 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-07-01
Decision Date2013-07-30
Summary:summary

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