đź“‹ FDA Reference
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 ?
510(k)
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.
FDA-Cleared Indications
- Use as a bipolar active-fixation lead in a cardiac pacing system when cardiac pacing is indicated.
- Use to establish electrical connection between a compatible pacemaker and the heart for treatment of indicated rhythm disorders.
Clinical Applications
- Implantation as part of a permanent pacemaker system for patients who require cardiac pacing.
- Placement in the appropriate cardiac chamber to deliver pacing impulses and sense cardiac electrical activity.
- Use during pacemaker implantation or lead revision when a bipolar, active-fixation lead is clinically appropriate.
Practical Considerations
- Confirm compatibility with the intended pacemaker generator and connector system before implantation.
- The active-fixation mechanism requires careful positioning and deployment in suitable cardiac tissue; follow the device labeling and implanting physician’s technique.
- Verify lead dimensions and length against the patient’s anatomy and the planned implant route.
- MRI eligibility cannot be assumed from the lead name alone. Determine whether the complete pacemaker system is labeled for MRI and follow all system-specific conditions.
- Consider standard contraindications and precautions for transvenous lead implantation, including infection, unsuitable vascular access, thrombosis, perforation risk, and inability to maintain safe lead position.
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.