đź“‹ 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.
Clinical Applications
This device is commonly used in the management of bradyarrhythmias, where the heart beats too slowly. It is typically employed in electrophysiology labs or operating rooms by cardiologists and cardiac surgeons. Patients who benefit from this device often include those with sick sinus syndrome or heart block, where maintaining an adequate heart rate is crucial.
Indications for Use
The FDA-cleared indications suggest this device is intended for patients requiring cardiac pacing due to conditions like slow heart rates or arrhythmias. It is particularly useful in scenarios where reliable long-term pacing is needed.
Practical Considerations
Clinicians should consider the lead's compatibility with existing pacemaker generators and the patient's specific anatomical considerations. Proper placement technique is crucial to ensure optimal performance and minimize complications.
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.