đź“‹ FDA Reference
medtronic model 5028 target tip bipolar implantable tined ventricular transvenous lead
Medtronic Vascular
Summary: The Medtronic Model 5028 Target Tip Bipolar Implantable Tined Ventricular Transvenous Lead is a medical device used in cardiac pacing. It is primarily utilized by cardiologists for patients requiring ventricular pacing.
FDA Clearance Information
Pathway
510K
Number
K933731 ↗
Decision Date
March 21, 1994
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
This device was cleared through the FDA 510k pathway on March 21, 1994. Manufactured by Medtronic Vascular, it is classified as a Class III device under product code DTB.
What It Is
The Medtronic Model 5028 is an implantable lead designed for ventricular pacing. It features a bipolar configuration and tined design, which helps secure the lead within the heart's ventricular tissue. The device is used to deliver electrical impulses to stimulate heart contractions, ensuring proper heart rhythm in patients with arrhythmias.
Clinical Applications
This lead is commonly used in the context of cardiac pacing, particularly for patients with bradycardia or heart block. It is typically implanted by cardiologists in a hospital setting, often during a pacemaker implantation procedure. The device is suitable for adult patients requiring long-term pacing support.
Indications for Use
The FDA indications suggest this lead is intended for patients who need ventricular pacing due to conditions like bradycardia or heart block. It is designed to help maintain adequate heart rate and rhythm.
Practical Considerations
The lead is available in various lengths to accommodate different patient anatomies and is compatible with most pacemaker generators. Proper implantation technique is crucial to ensure lead stability and function, with attention to securing the tines within the ventricular tissue.
Frequently Asked Questions
What is the Medtronic Model 5028 Target Tip Lead used for?
It is used for ventricular pacing in patients with arrhythmias such as bradycardia or heart block.
What specialties typically use this device?
Cardiologists and electrophysiologists typically use this device during pacemaker implantation procedures.
What are the FDA-cleared indications?
The device is indicated for patients requiring ventricular pacing to manage 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.