📋 FDA Reference
Endocardial Pacemaker Lead W Carbon Tip
Pacesetter Systems
Summary: The endocardial pacemaker lead with a carbon tip by Pacesetter Systems is a device used in cardiac pacing to manage arrhythmias. It is primarily used by cardiologists in hospital settings.
FDA Clearance Information
Pathway ?
PMA
Number ?
P800041 ↗
Decision Date ?
June 19, 1989
Product Code ?
DTB
Device Class ?
Class 3
Evidence ?
0 studies
This device was cleared through the FDA's premarket approval (PMA) pathway on June 19, 1989. Manufactured by Pacesetter Systems, it is classified as a Class III device under product code DTB.
What It Is
The endocardial pacemaker lead with a carbon tip is a specialized lead used in cardiac pacing systems. It is designed to be implanted within the heart's endocardial surface, where it delivers electrical impulses to regulate heart rhythms. The carbon tip is intended to enhance conductivity and reduce tissue reaction, improving the longevity and performance of the pacing system.
FDA-Cleared Indications
- Use as an endocardial lead component of a pacemaker system for cardiac pacing.
- Use in patients who require pacing for bradyarrhythmias or other clinically indicated slow heart rhythms, according to the compatible pacing system's labeling.
Clinical Applications
- Endocardial lead placement as part of permanent pacemaker implantation.
- Delivery of pacing impulses to the cardiac endocardium in patients requiring treatment for bradyarrhythmia.
- Use with a compatible pacemaker pulse generator and other labeled pacing-system components.
- Pacing support for patients with clinically indicated conduction disorders when permanent cardiac pacing is prescribed.
Practical Considerations
- The lead must be compatible with the selected pacemaker generator, connector configuration, and pacing system.
- Placement requires fluoroscopic or other appropriate cardiac imaging guidance and testing of sensing, pacing threshold, and lead impedance.
- The lead is implanted through a venous access route and advanced into a cardiac chamber; final positioning depends on the pacing indication and anatomy.
- MRI safety cannot be determined from the device name alone. The complete implanted system must be checked against current manufacturer and FDA labeling for MRI-conditional status.
- Potential complications include lead dislodgement, failure to capture or sense, venous thrombosis, infection, vascular injury, arrhythmia, and cardiac perforation.
Frequently Asked Questions
What is the endocardial pacemaker lead with a carbon tip used for?
It is used to provide cardiac pacing in patients with arrhythmias, particularly those with slow heart rates.
What specialties typically use this device?
Cardiologists and cardiac surgeons typically use this device in hospital settings, particularly in electrophysiology labs.
What are the FDA-cleared indications?
The device is indicated for patients requiring cardiac pacing due to conditions like bradyarrhythmias 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.