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apc implantable pacing lead
American Pacemaker
Summary: The APC Implantable Pacing Lead is a medical device used in cardiac pacing procedures to deliver electrical impulses to the heart. It is typically used by cardiologists and cardiac electrophysiologists in patients requiring pacemaker therapy.
FDA Clearance Information
Pathway
510K
Number
K812830 ↗
Decision Date
January 18, 1982
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The APC Implantable Pacing Lead was cleared through the FDA 510(k) pathway on January 18, 1982. Manufactured by American Pacemaker, it is classified as a Class III device under product code DTB.
What It Is
The APC Implantable Pacing Lead is a component of a pacemaker system, designed to be implanted in the heart to deliver electrical impulses that regulate heartbeats. It consists of a flexible, insulated wire that connects the pacemaker to the heart muscle. This device is crucial for patients with arrhythmias or heart block, providing reliable pacing to maintain adequate heart rhythm.
Clinical Applications
This device is commonly used in cardiology, particularly in the management of bradycardia and heart block. It is typically implanted in a hospital setting by a cardiologist or cardiac electrophysiologist. The pacing lead is suitable for adult and pediatric patients who require long-term cardiac pacing support.
Indications for Use
The APC Implantable Pacing Lead is indicated for patients who need cardiac pacing due to conditions like bradycardia or heart block. It helps maintain a regular heart rhythm by delivering electrical impulses to the heart muscle.
Practical Considerations
The pacing lead comes in various lengths and configurations to accommodate different patient anatomies and pacing needs. It is compatible with a range of pacemaker devices, and proper implantation technique is crucial for optimal performance and longevity.
Related Literature
The linked study, 'InSync Model 8040 (InSync) and InSync III Model 8042 (InSync III) Registry,' focused on the registry of specific pacemaker models. Although the abstract is not available, such studies typically evaluate device performance and patient outcomes. Limitations may include lack of detailed data and specific focus on certain device models.
Frequently Asked Questions
What is APC 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 cardiac electrophysiologists typically use this device in cardiac pacing procedures.
What are the FDA-cleared indications?
It is indicated for patients requiring cardiac pacing 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.