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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 510K
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.
Clinical Applications
This device is commonly used in cardiology and electrophysiology departments, particularly during follow-up visits for patients with implanted pacemakers. It is used in both outpatient and inpatient settings to assess and optimize pacemaker settings. The device is crucial for patients who exhibit symptoms of pacemaker malfunction or require routine pacemaker checks.
Indications for Use
The Analyzer Pacer System PSA-5 is indicated for use in patients with implanted pacemakers to ensure their devices are functioning correctly. It is used to evaluate pacing thresholds and sensing capabilities, which are critical for patient safety and effective pacemaker therapy.
Practical Considerations
The device typically interfaces with a variety of pacemaker models, offering compatibility with most systems. Clinicians should be familiar with the specific pacemaker model in use to ensure accurate testing. Proper technique in connecting and interpreting results is essential for effective use.
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.