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endocardial screw-in lead model 1028t
Pacesetter Systems
Summary: The endocardial screw-in lead model 1028t is a cardiac device used for pacing the heart. It is typically used by cardiologists in patients requiring pacemaker therapy.
FDA Clearance Information
Pathway
510K
Number
K902147 ↗
Decision Date
July 17, 1990
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The endocardial screw-in lead model 1028t was cleared via the FDA 510k pathway on July 17, 1990. Manufactured by Pacesetter Systems, it is classified as a Class III device.
What It Is
The endocardial screw-in lead model 1028t is a type of cardiac lead designed to be implanted in the heart's endocardium. It functions by delivering electrical impulses to stimulate heart contractions, essential for patients with bradycardia or heart block. The screw-in mechanism ensures stable attachment to the heart tissue, improving lead performance and patient outcomes.
Clinical Applications
This device is commonly used in cardiac pacing procedures, particularly in patients with slow heart rhythms or atrioventricular block. Cardiologists and electrophysiologists in hospital settings typically perform these procedures. The patient population includes those with symptomatic bradycardia or those who have undergone pacemaker implantation.
Indications for Use
The device is indicated for patients who require electrical stimulation of the heart due to conditions like bradycardia or heart block. It is suitable for individuals needing a reliable pacing lead as part of their pacemaker system.
Practical Considerations
The lead is designed to be compatible with various pacemaker generators. It is important to ensure proper lead placement and secure attachment to the heart tissue during implantation. Clinicians should be familiar with the screw-in technique for optimal results.
Frequently Asked Questions
What is the endocardial screw-in lead model 1028t used for?
It is used for cardiac pacing in patients with conditions like 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 electrical stimulation of the heart due to 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.