MODEL 841 ENDOCARDIAL TINED LEAD

Permanent Pacemaker Electrode

PACESETTER SYSTEMS

The following data is part of a premarket notification filed by Pacesetter Systems with the FDA for Model 841 Endocardial Tined Lead.

Pre-market Notification Details

Device IDK812816
510k NumberK812816
Device Name:MODEL 841 ENDOCARDIAL TINED LEAD
ClassificationPermanent Pacemaker Electrode
Applicant PACESETTER SYSTEMS 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 Received1981-10-07
Decision Date1981-10-29

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