📋 FDA Reference
Model 482-01 Bipolar Coaxial Pacing Lead
Intermedics
Summary: The model 482-01 bipolar coaxial pacing lead is a medical device used in cardiac pacing procedures. It is primarily utilized by cardiologists for patients requiring temporary or permanent pacing support.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K791378 ↗
Decision Date ?
September 12, 1979
Product Code ?
DTB
Device Class ?
Class 3
Evidence ?
0 studies
The model 482-01 bipolar coaxial pacing lead by Intermedics was cleared through the FDA 510k pathway on September 12, 1979. It is classified as a Class III device under product code DTB.
What It Is
The model 482-01 is a bipolar coaxial pacing lead designed for use in cardiac pacing. It functions by delivering electrical impulses to the heart muscle to maintain an adequate heart rate. The coaxial design allows for reliable signal transmission and durability, making it suitable for both temporary and permanent pacing applications.
FDA-Cleared Indications
- Cardiac pacing in patients who require electrical stimulation to maintain an adequate heart rate.
- Pacing for bradycardia associated with impaired cardiac impulse generation or conduction.
- Pacing for heart block or other conditions in which the heart's natural electrical conduction is inadequate.
Clinical Applications
- Connecting a cardiac pacemaker generator to the heart for delivery of pacing impulses.
- Use during cardiac pacing procedures for patients with clinically significant bradycardia.
- Use for pacing support in patients with heart block or impaired cardiac conduction.
- Placement in a hospital cardiac catheterization laboratory or operating room by appropriately trained cardiac specialists.
Practical Considerations
- The model 482-01 is a bipolar coaxial lead; the lead must be compatible with the selected pacemaker generator and connector system.
- Lead length should be selected for the patient's anatomy and intended route of placement.
- Accurate positioning and secure fixation are important to maintain reliable electrical contact and reduce lead displacement or malfunction.
- MRI safety cannot be assumed for this older lead or for a pacemaker system that includes it; the complete implanted system must be evaluated against current MRI-conditional labeling.
- Potential complications of cardiac pacing leads include dislodgement, loss of capture or sensing, infection, bleeding, vessel or cardiac injury, and lead fracture or insulation failure.
Frequently Asked Questions
What is the model 482-01 bipolar coaxial pacing lead used for?
It is used for cardiac pacing in patients with conditions like bradycardia or heart block to maintain an adequate heart rate.
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 needing cardiac pacing due to 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.