PIKOS LP 01, PIKOS LP E01

Implantable Pacemaker Pulse-generator

BIOTRONIK, INC.

The following data is part of a premarket notification filed by Biotronik, Inc. with the FDA for Pikos Lp 01, Pikos Lp E01.

Pre-market Notification Details

Device IDK945627
510k NumberK945627
Device Name:PIKOS LP 01, PIKOS LP E01
ClassificationImplantable Pacemaker Pulse-generator
Applicant BIOTRONIK, INC. 6024 JEAN ROAD Lake Oswego,  OR  97035
ContactLauren L Foote Christensen
CorrespondentLauren L Foote Christensen
BIOTRONIK, INC. 6024 JEAN ROAD Lake Oswego,  OR  97035
Product CodeDXY  
CFR Regulation Number870.3610 [🔎]
DecisionSe - Postmarket Surveillance Required (SESP)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-11-16
Decision Date1996-03-04
Summary:summary

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