PACESETTER SYSTEMS, INC. ENDOCARDIAL SCREW-IN LEAD

Pacemaker Lead Adaptor

PACESETTER SYSTEMS

The following data is part of a premarket notification filed by Pacesetter Systems with the FDA for Pacesetter Systems, Inc. Endocardial Screw-in Lead.

Pre-market Notification Details

Device IDK844857
510k NumberK844857
Device Name:PACESETTER SYSTEMS, INC. ENDOCARDIAL SCREW-IN LEAD
ClassificationPacemaker Lead Adaptor
Applicant PACESETTER SYSTEMS 12884 BRADLEY AVE. Sylmar,  CA  91342
ContactNestor Kusnierz
CorrespondentNestor Kusnierz
PACESETTER SYSTEMS 12884 BRADLEY AVE. Sylmar,  CA  91342
Product CodeDTD  
CFR Regulation Number870.3620 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1984-12-14
Decision Date1985-02-14

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