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Model 484-01 Bipolar Coaxial Pacing Lead
Intermedics
Summary: The Model 484-01 Bipolar Coaxial Pacing Lead is a medical device used in cardiac pacing procedures. It is primarily used by cardiologists and electrophysiologists to manage heart rhythm disorders.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K791377 ↗
Decision Date ?
September 12, 1979
Product Code ?
DTB
Device Class ?
Class 3
Evidence ?
0 studies
The Model 484-01 Bipolar Coaxial Pacing Lead was cleared by the FDA via the 510k pathway on September 12, 1979. Manufactured by Intermedics, it is classified as a Class 3 device.
What It Is
The Model 484-01 is a bipolar coaxial pacing lead designed for use in cardiac pacing. It functions by delivering electrical impulses from a pacemaker to the heart muscle, helping to maintain an adequate heart rate in patients with arrhythmias. The coaxial design refers to its structure, which enhances durability and reliability in transmitting electrical signals.
FDA-Cleared Indications
- Electrical pacing of the heart in patients requiring cardiac pacing.
- Pacing support for bradycardia, including slow heart rates caused by impaired cardiac conduction.
- Pacing support for atrioventricular block or other disruption of the heart’s normal electrical conduction.
Clinical Applications
- Implantation as part of a permanent pacemaker system.
- Delivery of pacing impulses from a compatible pacemaker generator to the heart muscle.
- Treatment of patients who require long-term pacing for bradycardia.
- Treatment of patients who require pacing for atrioventricular block.
Practical Considerations
- The lead is a bipolar coaxial design and must be connected to a compatible pacemaker generator.
- Lead length and configuration should be selected to match the patient’s anatomy and the intended cardiac chamber.
- Implantation requires imaging and electrical testing to confirm appropriate lead position, sensing and pacing function.
- MRI safety should not be assumed for this older lead. MRI eligibility depends on the complete implanted system and documented manufacturer labeling; the device should be treated as non-MRI-conditional unless confirmed otherwise.
- Contraindications, handling requirements and removal decisions should follow the original labeling and current clinical judgment. Lead extraction can carry substantial risks.
Frequently Asked Questions
What is the Model 484-01 Bipolar Coaxial Pacing Lead used for?
It is used for cardiac pacing in patients with heart rhythm disorders such as bradycardia or heart block.
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 electrical pacing of the heart due to conditions like 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.