đź“‹ FDA Reference
Analyzer Pacer System Psa-5
Edwards Pacemaker Systems
Summary: The Analyzer Pacer System PSA-5 is a medical device used to analyze and test pacemaker functionality. It is primarily used by cardiologists and electrophysiologists in clinical settings to ensure proper pacemaker operation.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K781144 ↗
Decision Date ?
August 23, 1978
Product Code ?
DTC
Device Class ?
Class 2
Evidence ?
0 studies
The Analyzer Pacer System PSA-5 was cleared through the FDA 510(k) pathway on August 23, 1978. Manufactured by Edwards Pacemaker Systems, it is classified as a Class 2 device under product code DTC.
What It Is
The Analyzer Pacer System PSA-5 is a diagnostic tool designed to evaluate the performance of pacemakers. It provides clinicians with the ability to test pacing thresholds, sensing capabilities, and battery status of implanted pacemakers. This device is essential for ensuring that pacemakers are functioning correctly and safely within patients.
FDA-Cleared Indications
- Analysis and testing of implanted pacemaker function.
- Evaluation of pacemaker pacing thresholds and sensing capabilities.
- Assessment of pacemaker performance during clinical follow-up or when malfunction is suspected.
Clinical Applications
- Testing pacing thresholds in patients with implanted pacemakers.
- Evaluating sensing function of implanted pacemaker systems.
- Assessing pacemaker performance during routine cardiology or electrophysiology follow-up.
- Supporting evaluation of suspected pacemaker malfunction or abnormal device performance.
Practical Considerations
- Compatibility depends on the implanted pacemaker model and the analyzer interface or lead connections; verify system compatibility before testing.
- Use requires trained cardiology or electrophysiology personnel who can connect the system and interpret pacing and sensing results.
- The available record does not establish that the analyzer itself is MRI safe or MR conditional; follow the device labeling and institutional MRI protocols.
- The analyzer evaluates an implanted pacemaker but does not replace clinical assessment, electrocardiography, device interrogation, or replacement of a malfunctioning pacemaker when indicated.
- The provided FDA record does not specify patient-applied sizes, implant dimensions, or a defined service life for the analyzer.
Frequently Asked Questions
What is the Analyzer Pacer System PSA-5 used for?
It is used to test and analyze the functionality of implanted pacemakers, ensuring they operate correctly.
What specialties typically use this device?
Cardiologists and electrophysiologists primarily use this device in clinical settings.
What are the FDA-cleared indications?
The device is indicated for evaluating the performance of implanted pacemakers, including testing pacing thresholds and sensing capabilities.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.