đź“‹ FDA Reference
perm implant endocardial pac lead
Daig
Summary: The perm implant endocardial pac lead by Daig is a device used in cardiac pacing. It is typically utilized by cardiologists for patients requiring long-term cardiac rhythm management.
FDA Clearance Information
Pathway
510K
Number
K770195 ↗
Decision Date
February 7, 1977
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The perm implant endocardial pac lead was cleared via the FDA 510k pathway on February 7, 1977. Manufactured by Daig, it is classified as a Class III device.
What It Is
The perm implant endocardial pac lead is a specialized lead used in pacemakers to deliver electrical impulses to the heart. It is designed to be implanted endocardially, meaning it is placed inside the heart's chambers. This device helps maintain adequate heart rhythm in patients with arrhythmias or heart block. Its design ensures stable electrical contact with the heart tissue, which is crucial for effective pacing.
Clinical Applications
This device is commonly used in the management of patients with bradycardia or heart block, where the heart beats too slowly. Cardiologists and electrophysiologists typically implant these leads in hospital settings, often during a pacemaker insertion procedure. It is suitable for a wide range of patients, including those with chronic atrial fibrillation or sinus node dysfunction.
Indications for Use
The perm implant endocardial pac lead is indicated for patients who require pacing due to arrhythmias such as heart block or bradycardia. It is suitable for individuals who need long-term cardiac rhythm management.
Practical Considerations
The device is available in various lengths to accommodate different patient anatomies. It is compatible with most pacemaker generators. Proper implantation technique is crucial to ensure lead stability and minimize complications such as lead dislodgement.
Frequently Asked Questions
What is the perm implant endocardial pac lead used for?
It is used for cardiac pacing in patients with arrhythmias such as bradycardia or heart block.
What specialties typically use this device?
Cardiologists and electrophysiologists typically use this device in hospital settings.
What are the FDA-cleared indications?
It is indicated for patients requiring pacing due to arrhythmias like heart block or 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.