MODIFICATION TO BIOTRONIK'S STERILIZATION PROCESS

Permanent Pacemaker Electrode

BIOTRONIK, INC.

The following data is part of a premarket notification filed by Biotronik, Inc. with the FDA for Modification To Biotronik's Sterilization Process.

Pre-market Notification Details

Device IDK023803
510k NumberK023803
Device Name:MODIFICATION TO BIOTRONIK'S STERILIZATION PROCESS
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 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-11-14
Decision Date2002-12-11

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