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model 486-01 pacemaker lead
Intermedics
Summary: The model 486-01 pacemaker lead by Intermedics is a cardiac device used to deliver electrical impulses to the heart. It is primarily used by cardiologists in patients requiring pacing support.
FDA Clearance Information
Pathway
510K
Number
K813135 ↗
Decision Date
April 3, 1985
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The model 486-01 pacemaker lead was cleared through the FDA 510k pathway on April 3, 1985. Manufactured by Intermedics, it is classified as a Class III device.
What It Is
The model 486-01 pacemaker lead is a component of a pacemaker system designed to deliver electrical impulses to the heart to maintain an adequate heart rate. It is implanted in the heart and connected to a pacemaker device, which regulates the heart's electrical activity. This lead is crucial for patients with arrhythmias or heart block, ensuring proper cardiac function.
Clinical Applications
This pacemaker lead is commonly used in cardiology, particularly in electrophysiology and cardiac surgery settings. It is indicated for patients with bradycardia, heart block, or other conditions requiring pacing. The device is typically used in hospital settings, including operating rooms and cardiac catheterization labs, and is essential for patients who need long-term pacing support.
Indications for Use
The FDA indications for this device include use in patients with symptomatic bradycardia or heart block. It is intended for individuals who require electrical stimulation to maintain a regular heart rhythm.
Practical Considerations
The model 486-01 pacemaker lead is compatible with most pacemaker devices. It is important to consider the lead's length and diameter when selecting it for implantation, ensuring it fits the patient's anatomy and the specific pacemaker model. Proper implantation technique is crucial for optimal performance and longevity.
Frequently Asked Questions
What is the model 486-01 pacemaker lead used for?
It is used to deliver electrical impulses to the heart in patients requiring pacing support due to conditions like bradycardia or heart block.
What specialties typically use this device?
Cardiologists, particularly those specializing in electrophysiology and cardiac surgery, typically use this device.
What are the FDA-cleared indications?
The device is indicated for patients with symptomatic bradycardia or heart block requiring electrical stimulation to maintain a regular heart rhythm.
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.