EX 45-BP, MODEL 330 132; EX 53-BP, MODEL 130 018; EX 60-BP, MODEL 330 133

Permanent Pacemaker Electrode

BIOTRONIK, INC.

The following data is part of a premarket notification filed by Biotronik, Inc. with the FDA for Ex 45-bp, Model 330 132; Ex 53-bp, Model 130 018; Ex 60-bp, Model 330 133.

Pre-market Notification Details

Device IDK994240
510k NumberK994240
Device Name:EX 45-BP, MODEL 330 132; EX 53-BP, MODEL 130 018; EX 60-BP, MODEL 330 133
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 [🔎]
DecisionSe Subject To Tracking Reg (ST)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-12-16
Decision Date2000-04-13
Summary:summary

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