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models 432-03 433-03 implant endocard pac lead
Intermedics
Summary: The implant endocard pac lead by Intermedics is a device used in cardiac pacing procedures. It is primarily used by cardiologists and cardiac surgeons to manage arrhythmias in patients requiring pacemaker implantation.
FDA Clearance Information
Pathway
510K
Number
K912235 ↗
Decision Date
September 18, 1991
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
This device was cleared through the FDA 510k pathway on September 18, 1991. Manufactured by Intermedics, it is classified as a Class III device under product code DTB.
What It Is
The implant endocard pac lead is a cardiac pacing lead designed to be implanted in the heart's endocardium. It functions as a conduit for electrical impulses from a pacemaker to the heart muscle, ensuring proper heart rhythm. The lead is typically inserted via a transvenous approach and secured within the heart chambers.
Clinical Applications
This device is commonly used in procedures involving the implantation of pacemakers, particularly for patients with bradycardia or other arrhythmias. It is utilized in both hospital and outpatient settings, predominantly by cardiologists and electrophysiologists. The patient population includes those with symptomatic heart block or sick sinus syndrome.
Indications for Use
The FDA-cleared indications for this device include use in patients who require cardiac pacing due to arrhythmias such as bradycardia. It is intended for individuals who need long-term rhythm management.
Practical Considerations
When considering this device, clinicians should be aware of the typical lead lengths and compatibility with various pacemaker models. Proper technique during insertion is crucial to avoid complications such as lead dislodgement or cardiac perforation.
Frequently Asked Questions
What is the implant endocard pac lead used for?
It is used for delivering electrical impulses from a pacemaker to the heart to manage arrhythmias.
What specialties typically use this device?
Cardiologists and electrophysiologists primarily use this device in cardiac pacing procedures.
What are the FDA-cleared indications?
It is indicated for patients requiring cardiac pacing due to arrhythmias like 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.