đź“‹ FDA Reference
Sea Med Ddd Pacing System Analyzer
Seamed
Summary: The Sea Med DDD Pacing System Analyzer is a medical device used to evaluate and optimize cardiac pacing systems. It is typically used by cardiologists and electrophysiologists in clinical settings.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K851900 ↗
Decision Date ?
July 19, 1985
Product Code ?
DTC
Device Class ?
Class 2
Evidence ?
0 studies
The Sea Med DDD Pacing System Analyzer was cleared through the FDA 510k pathway on July 19, 1985. Manufactured by Seamed, it is classified as a Class 2 device under product code DTC.
What It Is
The Sea Med DDD Pacing System Analyzer is a diagnostic tool designed to assess and optimize the function of dual-chamber pacemakers. It measures parameters such as pacing thresholds, lead impedance, and sensing capabilities. This device is crucial for ensuring that pacemakers are functioning correctly and efficiently, providing vital support for patients with cardiac arrhythmias.
FDA-Cleared Indications
- Evaluation of dual-chamber cardiac pacing systems.
- Measurement of pacemaker lead sensing, pacing thresholds, and lead impedance.
- Assessment and adjustment of dual-chamber pacemaker system function.
Clinical Applications
- Testing atrial and ventricular pacing thresholds during dual-chamber pacemaker implantation.
- Measuring lead impedance and sensing performance in an implanted dual-chamber pacing system.
- Supporting programming and optimization of dual-chamber pacemaker settings.
- Evaluating pacemaker system function during routine electrophysiology follow-up.
Practical Considerations
- The analyzer is intended for use by trained cardiac electrophysiology or cardiology professionals.
- Confirm compatibility with the pacemaker generator and leads before connection; follow the applicable device labeling and connection procedures.
- Proper calibration, sterile technique when used during implantation, and continuous patient monitoring are important.
- The analyzer itself is not an implanted device and does not provide long-term pacing therapy.
- MRI safety cannot be determined from the FDA record alone. MRI decisions should be based on the complete implanted pacemaker system and its current labeling.
Frequently Asked Questions
What is the Sea Med DDD Pacing System Analyzer used for?
It is used to evaluate and optimize the function of dual-chamber pacemakers, ensuring they are working correctly.
What specialties typically use this device?
Cardiologists and electrophysiologists typically use this device in clinical settings.
What are the FDA-cleared indications?
The device is indicated for the evaluation and optimization of dual-chamber pacing systems in patients with cardiac arrhythmias.
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.