đź“‹ FDA Reference
model a unipolar endocardial lead
Cook Pacemaker
Summary: The Model A Unipolar Endocardial Lead is a cardiac device used in pacemaker systems to transmit electrical impulses to the heart. It is typically used by cardiologists in patients with arrhythmias.
FDA Clearance Information
Pathway
510K
Number
K811879 ↗
Decision Date
August 3, 1981
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
This device was cleared through the FDA 510k pathway on August 3, 1981. Manufactured by Cook Pacemaker, it is classified as a Class III medical device.
What It Is
The Model A Unipolar Endocardial Lead is a component of a pacemaker system, designed to deliver electrical impulses directly to the heart muscle. It consists of a single electrode that contacts the endocardium, the inner lining of the heart. This lead is crucial for maintaining heart rhythm in patients with bradycardia or other rhythm disorders.
Clinical Applications
This lead is commonly used in cardiac electrophysiology, particularly in the implantation of pacemakers for patients with symptomatic bradycardia. It is utilized in both hospital and outpatient settings, primarily by cardiologists and electrophysiologists. The typical patient population includes those with heart block or sick sinus syndrome.
Indications for Use
The FDA indications suggest this device is used for patients requiring cardiac pacing due to arrhythmias. It is suitable for those with conditions like heart block or slow heart rates that necessitate electrical stimulation.
Practical Considerations
The unipolar design requires careful placement to ensure effective pacing. Compatibility with specific pacemaker generators should be verified. Typical sizing may vary, so clinicians should consult manufacturer guidelines for optimal fit.
Frequently Asked Questions
What is Model A Unipolar Endocardial Lead used for?
It is used to deliver electrical impulses to the heart in pacemaker systems, helping to regulate heart rhythm in patients with arrhythmias.
What specialties typically use this device?
Cardiologists and electrophysiologists typically use this device in the management of cardiac arrhythmias.
What are the FDA-cleared indications?
The device is indicated for patients requiring cardiac pacing due to arrhythmias such as heart block or slow heart rates.
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.