Pacing System Analyzer Psa Sce-22

FDA-Cleared Indications

• Evaluation of cardiac pacing and sensing parameters during pacemaker implantation.
• Assessment of pacemaker lead performance during an implantation procedure.

Clinical Applications

• Measuring pacing threshold, sensing, and lead impedance during pacemaker implantation.
• Checking electrical lead function before connection to an implanted pacemaker.
• Supporting selection and adjustment of pacing settings during an implant procedure.

Reported off-label uses

• Use during physiologic pacing procedures, such as left bundle branch area pacing, to assess lead electrical parameters when a full electrophysiology system is not available.

Off-label use: these uses are reported in practice or the literature but are not part of the FDA-cleared indications. Physicians may use a cleared device off-label based on their medical judgment; the manufacturer may not promote off-label uses.

Practical Considerations

• The analyzer is an external procedural instrument used with temporary connections to pacing leads; it is not an implanted pacemaker or lead.
• Compatibility depends on the pacing leads, connector cables, and accessories used during the procedure.
• Measurements should be interpreted by qualified cardiac implant personnel and confirmed with the permanent pacemaker system before closure.
• The available FDA record does not establish that the analyzer itself is MRI safe; MRI conditions must be confirmed from the current device labeling and the implanted pacemaker system.
• The FDA record provided does not specify a fixed implant duration because the analyzer is used during implantation rather than left in the body.