BIOTRONIK DN UNIPOLAR PE-60/4-DN &

Permanent Pacemaker Electrode

BIOTRONIK SALES, INC.

The following data is part of a premarket notification filed by Biotronik Sales, Inc. with the FDA for Biotronik Dn Unipolar Pe-60/4-dn &.

Pre-market Notification Details

Device IDK833098
510k NumberK833098
Device Name:BIOTRONIK DN UNIPOLAR PE-60/4-DN &
ClassificationPermanent Pacemaker Electrode
Applicant BIOTRONIK SALES, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeDTB  
CFR Regulation Number870.3680 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1983-09-12
Decision Date1983-10-19

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