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models 438-05 and 435-05 implantable pacing lead
Intermedics
Summary: The Intermedics implantable pacing lead models 438-05 and 435-05 are used in cardiac pacing to maintain heart rhythm. They are primarily used by cardiologists in patients requiring pacemaker implantation.
FDA Clearance Information
Pathway 510K
Number K922972 ↗
Decision Date January 22, 1993
Product Code DTB
Device Class Class 3
Evidence 0 studies
The implantable pacing lead models 438-05 and 435-05 by Intermedics were cleared via the FDA 510(k) pathway on January 22, 1993. These devices are classified as Class III under product code DTB.
What It Is
The implantable pacing leads are medical devices designed to deliver electrical impulses to the heart to regulate its rhythm. These leads are typically used in conjunction with a pacemaker, which is implanted in patients with arrhythmias or other heart rhythm disorders. The leads are inserted into the heart and connected to the pacemaker, allowing it to monitor and adjust the heart's electrical activity as needed.
Clinical Applications
These pacing leads are commonly used in cardiology, particularly in the implantation of pacemakers for patients with bradycardia, heart block, or other arrhythmias. They are typically used in hospital settings, including operating rooms and cardiac catheterization labs. The primary patient population includes adults with symptomatic heart rhythm disorders that require pacing support.
Indications for Use
The FDA indications for these pacing leads include use in patients who require cardiac pacing due to conditions such as bradycardia or heart block. These devices help maintain an adequate heart rate in patients whose natural pacemaker is not functioning properly.
Practical Considerations
When using these pacing leads, clinicians should consider the appropriate lead size and compatibility with the chosen pacemaker device. Proper technique during implantation is crucial to ensure optimal lead placement and function. It is important to follow manufacturer guidelines for implantation and maintenance.
Frequently Asked Questions
What is the implantable pacing lead used for?
The implantable pacing lead is used to deliver electrical impulses to the heart to regulate its rhythm in patients with arrhythmias.
What specialties typically use this device?
Cardiologists and electrophysiologists typically use this device during pacemaker implantation procedures.
What are the FDA-cleared indications?
The FDA-cleared indications include use in patients requiring cardiac pacing due to conditions like bradycardia or heart block.
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.