đź“‹ FDA Reference
model 492-01 pacemaker lead
Intermedics
Summary: The model 492-01 pacemaker lead by Intermedics is a cardiac device used to deliver electrical impulses to the heart. It is primarily used by cardiologists for patients requiring cardiac pacing.
FDA Clearance Information
Pathway
510K
Number
K813136 ↗
Decision Date
April 3, 1985
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
This device was cleared through the FDA 510k pathway on April 3, 1985. It is manufactured by Intermedics and classified as a Class III device under product code DTB.
What It Is
The model 492-01 pacemaker lead is an implantable device designed to transmit electrical impulses from a pacemaker to the heart muscle, ensuring proper heart rhythm. It consists of a flexible wire that connects to the pacemaker and is inserted into the heart's chambers, typically the right atrium or ventricle. This lead is crucial for patients with arrhythmias or heart block who require consistent cardiac pacing.
Clinical Applications
This pacemaker lead is commonly used in cardiology, particularly in electrophysiology and interventional cardiology settings. It is employed during procedures to manage bradycardia, heart block, or other rhythm disorders. Patients who benefit from this device include those with symptomatic bradycardia or those who have undergone procedures like AV node ablation.
Indications for Use
The FDA indications for this pacemaker lead include use in patients who require electrical pacing of the heart due to conditions like heart block or slow heart rate. It is suitable for individuals who need long-term cardiac rhythm management.
Practical Considerations
Clinicians should consider the lead's compatibility with the pacemaker generator and the patient's anatomy. Proper sizing and placement technique are crucial for optimal performance and longevity of the device. Regular follow-up is necessary to ensure device functionality.
Frequently Asked Questions
What is the model 492-01 pacemaker lead used for?
It is used to deliver electrical impulses to the heart to maintain a regular heart rhythm in patients with arrhythmias.
What specialties typically use this device?
Cardiologists, particularly those specializing in electrophysiology and interventional cardiology, typically use this device.
What are the FDA-cleared indications?
The device is indicated for patients requiring cardiac pacing due to conditions like heart block or symptomatic bradycardia.
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.