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models 432-03 433-03 implantable pacing leads
Intermedics
Summary: The Intermedics implantable pacing leads (models 432-03 and 433-03) are used in cardiac pacing systems to help manage heart rhythm disorders. They are primarily used by cardiologists in hospital settings.
FDA Clearance Information
Pathway
510K
Number
K890411 ↗
Decision Date
March 28, 1989
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The Intermedics implantable pacing leads received FDA clearance through the 510(k) pathway on March 28, 1989. Manufactured by Intermedics, these leads are classified as Class III medical devices.
What It Is
The implantable pacing leads by Intermedics are components of cardiac pacing systems. They are designed to deliver electrical impulses from a pacemaker to the heart muscle, ensuring proper heart rhythm. These leads are typically inserted into the heart via a vein and are anchored to the heart tissue to maintain consistent contact.
Clinical Applications
These pacing leads are commonly used in patients with bradycardia or other arrhythmias requiring electrical pacing to maintain adequate heart rates. Cardiologists and electrophysiologists typically use these devices in hospital settings, particularly in cardiac catheterization labs or during surgical implantation of pacemakers. They are suitable for adult patients who require long-term cardiac pacing.
Indications for Use
The FDA indications for these pacing leads include use in patients who require electrical pacing to manage heart rhythm disorders. This typically involves individuals with conditions like bradycardia, where the heart beats too slowly.
Practical Considerations
These leads come in various lengths to accommodate different patient anatomies and are compatible with a range of pacemaker devices. Proper placement and secure anchoring are crucial for effective pacing and minimizing lead dislodgement.
Frequently Asked Questions
What is the implantable pacing lead used for?
It is used to deliver electrical impulses from a pacemaker to the heart to manage heart rhythm disorders.
What specialties typically use this device?
Cardiologists and electrophysiologists typically use this device in hospital settings.
What are the FDA-cleared indications?
The leads are indicated for patients needing electrical pacing due to heart rhythm disorders like bradycardia.
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.