VS-1 MODEL NUMBER 251K PULSE GENERATOR

Implantable Pacemaker Pulse-generator

PACESETTER SYSTEMS

The following data is part of a premarket notification filed by Pacesetter Systems with the FDA for Vs-1 Model Number 251k Pulse Generator.

Pre-market Notification Details

Device IDK885267
510k NumberK885267
Device Name:VS-1 MODEL NUMBER 251K PULSE GENERATOR
ClassificationImplantable Pacemaker Pulse-generator
Applicant PACESETTER SYSTEMS 12884 BRADLEY AVE. Sylmar,  CA  91342
ContactNestor Kusnierz
CorrespondentNestor Kusnierz
PACESETTER SYSTEMS 12884 BRADLEY AVE. Sylmar,  CA  91342
Product CodeDXY  
CFR Regulation Number870.3610 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-12-22
Decision Date1989-03-28

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.