📋 FDA Reference
Implantable Electrode Lead Model 030-400
Telectronics
Summary: The implantable electrode lead model 030-400 by Telectronics is used in cardiac pacing systems. It is primarily utilized by cardiologists for patients requiring cardiac rhythm management.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K852972 ↗
Decision Date ?
September 16, 1985
Product Code ?
DTB
Device Class ?
Class 3
Evidence ?
0 studies
The implantable electrode lead model 030-400 by Telectronics was cleared through the FDA 510k process on September 16, 1985. It is classified as a Class 3 device under product code DTB.
What It Is
The implantable electrode lead model 030-400 is a component of cardiac pacemaker systems. It functions by delivering electrical impulses from the pacemaker to the heart muscle, ensuring proper heart rhythm. The lead is designed to be implanted within the heart or attached to the heart's surface, facilitating effective cardiac pacing.
FDA-Cleared Indications
- Use as part of a cardiac pacing system for patients who require cardiac pacing because of an abnormal heart rhythm.
- Use in patients with heart block or inadequate heart rates when pacing therapy is clinically indicated.
- Use to deliver electrical stimulation between a compatible pacemaker generator and the heart.
Clinical Applications
- Implantation as a component of a permanent pacemaker system.
- Cardiac pacing for selected patients with clinically significant bradyarrhythmias.
- Cardiac pacing for selected patients with atrioventricular or other forms of heart block.
- Connection between a pacemaker generator and the cardiac tissue requiring stimulation.
Practical Considerations
- The lead must be matched to a compatible pacemaker generator and pacing system.
- Implantation requires appropriate lead selection, positioning, testing and fixation according to the device labeling and clinical situation.
- The lead may be placed in a cardiac chamber or on the heart surface, depending on the lead design and pacing approach.
- MRI safety cannot be determined from the 1985 510(k) record alone; patients should be evaluated using the complete implanted system and current manufacturer and FDA guidance.
- Contraindications, lead integrity, infection risk and long-term electrical performance should be assessed before implantation and during follow-up.
Frequently Asked Questions
What is implantable electrode lead model 030-400 used for?
It is used in cardiac pacing systems to manage heart rhythm disorders.
What specialties typically use this device?
Cardiologists and electrophysiologists typically use this device.
What are the FDA-cleared indications?
The device is indicated for patients requiring cardiac pacing due to arrhythmias or heart block.
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.