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implantable pacing lead models 487-06 to 430-01
Intermedics
Summary: The implantable pacing lead models 487-06 to 430-01 by Intermedics are used in cardiac pacing systems to deliver electrical impulses to the heart. They are primarily used by cardiologists in patients requiring pacemaker therapy.
FDA Clearance Information
Pathway
510K
Number
K871580 ↗
Decision Date
May 22, 1987
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
These implantable pacing leads were cleared through the FDA 510(k) pathway on May 22, 1987. Manufactured by Intermedics, they are classified as Class III medical devices.
What It Is
The implantable pacing lead models 487-06 to 430-01 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 implanted into the heart via a transvenous approach and are crucial for patients with arrhythmias requiring consistent cardiac pacing.
Clinical Applications
These pacing leads are commonly used in cardiology, particularly in electrophysiology settings. They are implanted in patients with bradycardia or heart block who require a pacemaker to maintain adequate heart rate and rhythm. The procedure is typically performed in a hospital setting, involving a multidisciplinary team including cardiologists and electrophysiologists.
Indications for Use
The FDA indications for these pacing leads include use in patients with conditions such as bradycardia or atrioventricular block, where electrical pacing is necessary to maintain heart function. They are suitable for patients who require long-term pacing therapy.
Practical Considerations
These leads come in various sizes to accommodate different patient anatomies and are compatible with a range of pacemaker devices. Proper lead placement and secure fixation are critical to ensure effective pacing and minimize complications such as lead dislodgement.
Frequently Asked Questions
What is implantable pacing lead models 487-06 to 430-01 used for?
These leads are used in cardiac pacing systems to deliver electrical impulses to the heart, ensuring proper heart rhythm in patients with arrhythmias.
What specialties typically use this device?
Cardiologists, particularly those specializing in electrophysiology, typically use these devices in hospital settings.
What are the FDA-cleared indications?
These leads are indicated for use in patients with bradycardia or heart block who require electrical pacing to maintain heart function.
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.