LOW PROFILE LEAD CONNECTOR MODIFICATION (4002)

Permanent Pacemaker Electrode

MEDTRONIC VASCULAR

The following data is part of a premarket notification filed by Medtronic Vascular with the FDA for Low Profile Lead Connector Modification (4002).

Pre-market Notification Details

Device IDK801284
510k NumberK801284
Device Name:LOW PROFILE LEAD CONNECTOR MODIFICATION (4002)
ClassificationPermanent Pacemaker Electrode
Applicant MEDTRONIC VASCULAR 7000 CENTRAL AVE. NE Minneapolis,  MN  55432 -3576
ContactKeith J Proctor
CorrespondentKeith J Proctor
MEDTRONIC VASCULAR 7000 CENTRAL AVE. NE Minneapolis,  MN  55432 -3576
Product CodeDTB  
CFR Regulation Number870.3680 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1980-05-29
Decision Date1980-12-01

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