BIOTRONIK ENDOCARDIAL PACING LEADS

Permanent Pacemaker Electrode

BIOTRONIK, INC.

The following data is part of a premarket notification filed by Biotronik, Inc. with the FDA for Biotronik Endocardial Pacing Leads.

Pre-market Notification Details

Device IDK061212
510k NumberK061212
Device Name:BIOTRONIK ENDOCARDIAL PACING LEADS
ClassificationPermanent Pacemaker Electrode
Applicant BIOTRONIK, INC. 6024 JEAN ROAD Lake Oswego,  OR  97035
ContactJon Brumbaugh
CorrespondentJon Brumbaugh
BIOTRONIK, INC. 6024 JEAN ROAD Lake Oswego,  OR  97035
Product CodeDTB  
CFR Regulation Number870.3680 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-05-01
Decision Date2006-07-10
Summary:summary

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