BIPOLAR IMPLANTABLE ENDOCARDIAL PACING LEADS, WITH SILICONE RUBBER INSULATION AND PASSIVE FIXATION

Permanent Pacemaker Electrode

BIOTRONIK, INC.

The following data is part of a premarket notification filed by Biotronik, Inc. with the FDA for Bipolar Implantable Endocardial Pacing Leads, With Silicone Rubber Insulation And Passive Fixation.

Pre-market Notification Details

Device IDK964604
510k NumberK964604
Device Name:BIPOLAR IMPLANTABLE ENDOCARDIAL PACING LEADS, WITH SILICONE RUBBER INSULATION AND PASSIVE FIXATION
ClassificationPermanent Pacemaker Electrode
Applicant BIOTRONIK, INC. 6024 JEAN ROAD Lake Oswego,  OR  97035
ContactJoseph J Schwoebel, Rac
CorrespondentJoseph J Schwoebel, Rac
BIOTRONIK, INC. 6024 JEAN ROAD Lake Oswego,  OR  97035
Product CodeDTB  
CFR Regulation Number870.3680 [🔎]
DecisionSe Subject To Traking & Pms (PT)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-11-18
Decision Date1997-03-10
Summary:summary

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