📋 FDA Reference
Lifeline Unipolar J-Lead 483-05
Intermedics
Summary: The Lifeline Unipolar J-Lead 483-05 is a cardiac lead used in pacemaker systems. It is typically used by cardiologists to manage arrhythmias in patients requiring pacing therapy.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K830463 ↗
Decision Date ?
February 28, 1983
Product Code ?
DTB
Device Class ?
Class 3
Evidence ?
0 studies
The Lifeline Unipolar J-Lead 483-05 was cleared through the FDA 510(k) pathway on February 28, 1983. Manufactured by Intermedics, it is classified as a Class III device.
What It Is
The Lifeline Unipolar J-Lead 483-05 is a cardiac pacing lead designed for use in conjunction with pacemakers. It features a unipolar configuration, which means it has a single electrode for delivering electrical impulses to the heart. The 'J' shape of the lead is designed to facilitate placement in the right atrium or ventricle, ensuring stable contact with cardiac tissue.
FDA-Cleared Indications
- Use as a cardiac pacing lead in conjunction with a compatible pacemaker system.
- Use in patients requiring electrical pacing for bradycardia or other rhythm disturbances, as specified by the compatible pacemaker system's labeling.
Clinical Applications
- Placement as part of a permanent pacemaker implantation.
- Delivery of pacing impulses to cardiac tissue through a unipolar electrode configuration.
- Use in patients requiring pacing for clinically significant slow heart rates or other indications covered by the pacemaker system labeling.
- Use by qualified cardiology or cardiac electrophysiology teams in an appropriate hospital or cardiac procedure setting.
Practical Considerations
- The lead is a unipolar design and must be connected to a compatible pacemaker generator and system configuration.
- The J-shaped design is intended to assist positioning and stability in the heart; final placement depends on patient anatomy and the intended pacing chamber.
- Available lead length and connector compatibility should be confirmed before implantation.
- MRI safety cannot be determined from this lead record alone. The lead and connected pacemaker system should be evaluated as a complete system under current manufacturer and FDA labeling before MRI.
- Implantation, testing, repositioning and removal should be performed by clinicians trained in cardiac pacing. Contraindications and warnings depend on the lead, generator and patient-specific anatomy and conditions.
Frequently Asked Questions
What is Lifeline Unipolar J-Lead 483-05 used for?
It is used in pacemaker systems to deliver electrical impulses to the heart in patients with arrhythmias.
What specialties typically use this device?
Cardiologists and electrophysiologists typically use this device in cardiac pacing procedures.
What are the FDA-cleared indications?
The device is indicated for patients requiring pacing due to arrhythmias such as bradycardia.
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.