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models 430-07 431-07 implantable pacing leads
Intermedics
Summary: The Intermedics implantable pacing leads are used in cardiac pacing systems to help manage heart rhythm disorders. They are typically used by cardiologists in hospital settings.
FDA Clearance Information
Pathway
510K
Number
K890412 ↗
Decision Date
March 28, 1989
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The Intermedics implantable pacing leads were cleared through the FDA 510(k) pathway on March 28, 1989. Manufactured by Intermedics, these leads are classified as Class III devices.
What It Is
The implantable pacing leads are components of cardiac pacing systems designed to deliver electrical impulses to the heart to maintain an appropriate heart rate and rhythm. These leads are implanted into the heart muscle and connected to a pacemaker device, which regulates heartbeats in patients with arrhythmias or heart block. The leads are crucial for ensuring the pacemaker's signals reach the heart effectively.
Clinical Applications
These pacing leads are commonly used in procedures involving the implantation of pacemakers, particularly in patients with bradycardia or atrioventricular block. Cardiologists and electrophysiologists typically perform these procedures in hospital settings, often in specialized cardiac care units. The patient population includes those with symptomatic heart rhythm disorders requiring long-term pacing support.
Indications for Use
The FDA indications suggest these leads are for patients needing cardiac pacing due to arrhythmias or heart block. They are suitable for individuals who require consistent heart rate management to prevent symptoms like dizziness or fainting.
Practical Considerations
These leads come in various lengths and configurations to accommodate different patient anatomies and pacing requirements. They are compatible with most pacemaker devices, but clinicians should verify compatibility with specific pacemaker models. Proper implantation technique is crucial to ensure lead stability and function.
Frequently Asked Questions
What is the implantable pacing lead used for?
It is used to deliver electrical impulses to the heart to regulate heartbeats in patients with arrhythmias or heart block.
What specialties typically use this device?
Cardiologists and electrophysiologists commonly use these leads in cardiac pacing procedures.
What are the FDA-cleared indications?
The leads are indicated for patients requiring cardiac pacing due to arrhythmias or heart block to maintain an appropriate heart rate.
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.