PROGRAMMALITH II, #225 & 226

Implantable Pacemaker Pulse-generator

PACESETTER SYSTEMS

The following data is part of a premarket notification filed by Pacesetter Systems with the FDA for Programmalith Ii, #225 & 226.

Pre-market Notification Details

Device IDK821003
510k NumberK821003
Device Name:PROGRAMMALITH II, #225 & 226
ClassificationImplantable Pacemaker Pulse-generator
Applicant PACESETTER SYSTEMS 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeDXY  
CFR Regulation Number870.3610 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1982-04-09
Decision Date1982-05-07

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