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model 329-701 bipolar active-fixation lead
Telectronics And Cordis Pacing Systems
Summary: The model 329-701 bipolar active-fixation lead is a medical device used in cardiac pacing systems. It is primarily utilized by cardiologists and electrophysiologists for patients requiring pacemaker implantation.
FDA Clearance Information
Pathway
510K
Number
K883265 ↗
Decision Date
October 14, 1988
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The model 329-701 bipolar active-fixation lead was cleared by the FDA through the 510(k) pathway on October 14, 1988. It is manufactured by Telectronics And Cordis Pacing Systems and classified as a Class III device.
What It Is
The model 329-701 is a bipolar active-fixation lead designed for use in cardiac pacing systems. It features an active-fixation mechanism that allows for secure attachment to the heart tissue, ensuring stable electrical conduction. This lead is typically used in conjunction with pacemakers to deliver electrical impulses to the heart, helping to regulate heart rhythms in patients with arrhythmias.
Clinical Applications
This lead is commonly used in procedures involving the implantation of pacemakers, particularly in patients with bradycardia or other rhythm disorders. Cardiologists and electrophysiologists often employ this device in hospital settings, including operating rooms and catheterization labs. It is suitable for a wide range of patient populations, including those with structural heart disease or post-surgical cardiac complications.
Indications for Use
The FDA indications suggest that this lead is intended for patients who require cardiac pacing due to arrhythmias. It is particularly beneficial for individuals with slow heart rates or irregular heartbeats that necessitate the use of a pacemaker.
Practical Considerations
When using the model 329-701 lead, clinicians should consider its compatibility with various pacemaker models. The active-fixation mechanism requires careful placement to ensure optimal performance. Typical sizing should be verified against patient anatomy to ensure proper fit and function.
Frequently Asked Questions
What is the model 329-701 bipolar active-fixation lead used for?
It is used in cardiac pacing systems to help regulate heart rhythms in patients with arrhythmias.
What specialties typically use this device?
Cardiologists and electrophysiologists typically use this device during pacemaker implantation procedures.
What are the FDA-cleared indications?
The lead is indicated for patients requiring cardiac pacing due to arrhythmias, particularly those with slow or irregular heartbeats.
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.