📋 FDA Reference
Lifeline Endocardial Bipolar Lead 484-03
Intermedics
Summary: The Lifeline Endocardial Bipolar Lead 484-03 is a cardiac lead used in pacemaker systems to deliver electrical impulses to the heart. It is typically used by cardiologists in hospital settings.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K853519 ↗
Decision Date ?
October 24, 1985
Product Code ?
DTB
Device Class ?
Class 3
Evidence ?
0 studies
The Lifeline Endocardial Bipolar Lead 484-03 was cleared through the FDA 510(k) pathway on October 24, 1985. Manufactured by Intermedics, it is classified as a Class III device.
What It Is
The Lifeline Endocardial Bipolar Lead 484-03 is a specialized cardiac lead designed for use in pacemaker systems. It functions by transmitting electrical impulses from the pacemaker to the heart muscle, ensuring proper heart rhythm. The bipolar design allows for more precise sensing and pacing, which is crucial for effective cardiac management.
FDA-Cleared Indications
- Use as an endocardial bipolar lead with a compatible cardiac pacemaker system.
- Provide cardiac pacing for patients with conditions requiring electrical stimulation of the heart.
Clinical Applications
- Endocardial lead placement during implantation of a permanent pacemaker system.
- Delivery of pacing impulses to the heart in patients who require long-term cardiac pacing.
- Sensing cardiac electrical activity through a bipolar pacing configuration.
- Management of bradyarrhythmias or conduction disorders when pacemaker therapy is indicated.
Practical Considerations
- Verify connector type, electrical specifications, lead dimensions and overall compatibility with the intended pacemaker generator before implantation.
- Lead placement and testing should be performed by qualified cardiac specialists using appropriate fluoroscopic and electrical measurements.
- The record provided does not establish that this specific lead is MRI conditional; MRI safety should be confirmed from the original labeling and the complete implanted system.
- Assess for patient-specific contraindications to transvenous lead implantation, including active infection, significant venous obstruction or anatomy that prevents safe placement.
- Lead longevity varies with implant conditions, mechanical stress, electrical performance and generator replacement history; ongoing pacemaker follow-up is required.
Frequently Asked Questions
What is the Lifeline Endocardial Bipolar Lead 484-03 used for?
It is used for cardiac pacing in patients with arrhythmias, such as bradycardia, to maintain a regular heart rhythm.
What specialties typically use this device?
Cardiologists and electrophysiologists typically use this device in hospital and specialized cardiac care settings.
What are the FDA-cleared indications?
The device is indicated for patients requiring cardiac pacing due to irregular heart rhythms, such as 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.