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electrode pacer system analyzer pma 400
Telectronics
Summary: The Electrode Pacer System Analyzer PMA 400 is a medical device used to evaluate and ensure the proper functioning of pacemaker electrodes. It is primarily used by cardiologists and electrophysiologists during pacemaker implantation or maintenance procedures.
FDA Clearance Information
Pathway 510K
Number K810604 ↗
Decision Date April 14, 1981
Product Code DTC
Device Class Class 2
Evidence 0 studies
The Electrode Pacer System Analyzer PMA 400, manufactured by Telectronics, received FDA clearance through the 510(k) pathway on April 14, 1981. It is classified as a Class 2 device under product code DTC.
What It Is
The Electrode Pacer System Analyzer PMA 400 is a diagnostic tool used to assess the functionality and integrity of pacemaker electrodes. It measures electrical parameters such as impedance, sensing thresholds, and pacing thresholds to ensure optimal performance of the pacemaker system. This device is crucial during the implantation of pacemakers to verify correct lead placement and during follow-up visits to monitor lead performance.
Clinical Applications
This device is commonly used in cardiology and electrophysiology settings, particularly during pacemaker implantation surgeries and routine follow-up appointments. It is essential for evaluating the electrical performance of pacemaker leads in patients requiring cardiac pacing. The analyzer helps clinicians ensure that the pacemaker system is functioning correctly, which is critical for patient safety and effective cardiac rhythm management.
Indications for Use
The Electrode Pacer System Analyzer PMA 400 is indicated for use in patients undergoing pacemaker implantation or those with existing pacemakers who require lead evaluation. It helps in assessing the electrical performance of pacemaker leads to ensure they are functioning properly.
Practical Considerations
When using the Electrode Pacer System Analyzer PMA 400, clinicians should be aware of the compatibility with various pacemaker models and electrode types. Proper technique in connecting the analyzer to the pacemaker leads is essential for accurate measurements. Regular calibration and maintenance of the device are recommended to ensure reliable performance.
Frequently Asked Questions
What is the Electrode Pacer System Analyzer PMA 400 used for?
It is used to evaluate the electrical performance of pacemaker electrodes during implantation and follow-up visits.
What specialties typically use this device?
Cardiologists and electrophysiologists typically use this device in hospital and clinical settings.
What are the FDA-cleared indications?
It is indicated for assessing the functionality of pacemaker electrodes in patients undergoing pacemaker implantation or maintenance.
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.