Device Dossier

PSA 300 Pacing System Analyzer - Pacemaker, cardiac, external, invasive

Device Dossier for PSA 300 Pacing System Analyzer - Pacemaker, cardiac, external, invasive (Pacemaker, cardiac, external, invasive, Class III, sponsor…

Intended purpose

PSA 300™ is a special temporary cardiac pacemaker intended for the analysis of implanted stimulation lead systems which supports all necessary and appropriate measurements and checks during the implantation of pacemakers and defibrillators.

Functional description

PSA 300 is utilized during pacemaker or defibrillator implantation for assessment of stimulation and sensing properties of the cardiac lead system. It provides the multiple measurement functions, including but not limited to determination of cardiac capture thresholds in atrium and ventricles, automatic measurement of P-/R-wave amplitudes and their slew rates, QRS amplitude from selected surface ECG vector, and estimation of lead impedance of the atrial and ventricular lead systems.

TGA Public Summary