TYPE YR ENDOCARDIAL LEAD

Permanent Pacemaker Electrode

BIOTRONIK SALES, INC.

The following data is part of a premarket notification filed by Biotronik Sales, Inc. with the FDA for Type Yr Endocardial Lead.

Pre-market Notification Details

Device IDK810492
510k NumberK810492
Device Name:TYPE YR ENDOCARDIAL LEAD
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 Received1981-02-24
Decision Date1981-03-20

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