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myopore tm unipolar models 1117 1118 pace leads
Possis Medical
Summary: The myopore tm unipolar models 1117 and 1118 are pacing leads used in cardiac pacing systems. They are primarily used by cardiologists to manage patients with arrhythmias requiring pacing support.
FDA Clearance Information
Pathway
510K
Number
K896443 ↗
Decision Date
December 20, 1989
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The myopore tm unipolar models 1117 and 1118 pace leads were cleared through the FDA 510(k) pathway on December 20, 1989. Manufactured by Possis Medical, these devices are classified as Class III under product code DTB.
What It Is
The myopore tm unipolar models 1117 and 1118 are pacing leads designed for use in cardiac pacing systems. These leads are implanted in the heart to deliver electrical impulses that regulate heartbeats in patients with arrhythmias. Unipolar leads have a single electrode that contacts the heart tissue, providing a pathway for electrical signals.
Clinical Applications
These pacing leads are commonly used in the management of bradycardia, where the heart beats too slowly. Cardiologists implant these leads during procedures in hospital settings, particularly in cardiac catheterization labs. They are suitable for adult patients who require long-term pacing therapy due to conditions like sick sinus syndrome or heart block.
Indications for Use
The FDA indications suggest these leads are for patients needing cardiac pacing support, typically those with slow heart rhythms. They are critical for maintaining adequate heart rates in patients with conduction system diseases.
Practical Considerations
The myopore tm unipolar leads come in various lengths to accommodate different patient anatomies. They are compatible with most pacemaker generators. Clinicians should be aware of the implantation technique, ensuring proper placement and secure fixation within the heart tissue.
Frequently Asked Questions
What is myopore tm unipolar models 1117 1118 pace leads used for?
These leads are used in cardiac pacing systems to regulate heartbeats in patients with arrhythmias.
What specialties typically use this device?
Cardiologists and electrophysiologists typically use these pacing leads in cardiac care settings.
What are the FDA-cleared indications?
These leads are indicated for patients requiring cardiac pacing support, particularly those with slow heart rhythms or conduction system diseases.
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.