đź“‹ FDA Reference
model 486-01 pacing lead
Intermedics
Summary: The model 486-01 pacing lead is a cardiac pacing device used in conjunction with pacemakers to regulate heart rhythms. It is primarily used by cardiologists and electrophysiologists in hospital settings.
FDA Clearance Information
Pathway
510K
Number
K844259 ↗
Decision Date
March 28, 1985
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The model 486-01 pacing lead by Intermedics was cleared through the FDA 510k pathway on March 28, 1985. It is classified as a Class III device, indicating it is used in life-sustaining situations.
What It Is
The model 486-01 pacing lead is a component of a cardiac pacing system, designed to deliver electrical impulses from a pacemaker to the heart muscle. It is typically implanted in patients who have arrhythmias or heart block, helping to maintain an adequate heart rate. The lead is inserted transvenously and positioned within the heart chambers, where it senses and stimulates cardiac activity.
Clinical Applications
This pacing lead is commonly used in procedures to treat bradycardia or heart block, conditions where the heart beats too slowly. It is typically used in cardiology and electrophysiology departments, often in hospital settings or specialized cardiac centers. Patients who benefit from this device include those with symptomatic bradycardia or those who have undergone cardiac surgery.
Indications for Use
The FDA indications for the model 486-01 pacing lead include use in patients with heart rhythm disorders such as bradycardia or heart block. It is intended for individuals who require electrical pacing to maintain a normal heart rate.
Practical Considerations
The model 486-01 pacing lead is available in various lengths to accommodate different patient anatomies. It is compatible with a range of pacemakers and requires careful placement to ensure effective pacing and sensing. Proper technique during implantation is crucial to avoid complications such as lead dislodgement.
Frequently Asked Questions
What is the model 486-01 pacing lead used for?
It is used to deliver electrical impulses from a pacemaker to the heart to regulate heart rhythms in patients with arrhythmias.
What specialties typically use this device?
Cardiologists and electrophysiologists typically use this device in hospital settings or specialized cardiac centers.
What are the FDA-cleared indications?
It is indicated for patients with heart rhythm disorders such as bradycardia or heart block who require electrical pacing.
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.