đź“‹ FDA Reference
Lifeline -Unipolar Lead 487-05
Intermedics
Summary: The lifeline -unipolar lead 487-05 by Intermedics is a medical device used in cardiac procedures, specifically for pacing. It is typically used by cardiologists in hospital settings.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K823508 ↗
Decision Date ?
January 14, 1983
Product Code ?
DTB
Device Class ?
Class 3
Evidence ?
0 studies
The lifeline -unipolar lead 487-05 received FDA clearance through the 510k pathway on January 14, 1983. Manufactured by Intermedics, it is classified as a Class III device.
What It Is
The lifeline -unipolar lead 487-05 is a cardiac pacing lead used in conjunction with pacemakers to deliver electrical impulses to the heart. It is designed to be implanted within the heart's chambers, providing a pathway for electrical signals to regulate heartbeats. As a unipolar lead, it uses a single electrode to connect with the heart tissue, which can be advantageous in certain pacing scenarios.
FDA-Cleared Indications
- Cardiac pacing in patients who require electrical stimulation to maintain an adequate heart rate.
- Pacing support for bradycardia, including slow heart rates associated with conduction disorders.
- Use with a compatible pacemaker system when a unipolar pacing lead configuration is indicated.
Clinical Applications
- Implantation as part of a permanent pacemaker system.
- Delivery of pacing impulses to cardiac tissue in patients requiring ongoing rhythm support.
- Use during cardiac pacing procedures for patients with bradycardia or heart block.
- Placement in a cardiac chamber selected by the treating cardiologist according to the pacing indication and device labeling.
Practical Considerations
- Confirm compatibility with the selected pacemaker generator, connector, and pacing system before implantation.
- The lead must be appropriately sized and positioned for the patient's cardiac anatomy and intended chamber.
- Unipolar systems may be more susceptible to electrical interference and may require careful sensing and programming.
- Implantation requires sterile technique, fluoroscopic or other appropriate imaging guidance, and testing of pacing and sensing performance.
- MRI safety cannot be assumed for this older lead or for a pacemaker system containing it; review the complete implanted system and current manufacturer and FDA information before MRI.
Frequently Asked Questions
What is lifeline -unipolar lead 487-05 used for?
It is used for cardiac pacing, delivering electrical impulses to the heart to regulate heartbeats in patients with bradycardia or heart block.
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 bradycardia or heart block, providing electrical stimulation to maintain heart rhythm.
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.