📋 FDA Reference
Model 483-01 Pacing Lead
Intermedics
Summary: The model 483-01 pacing lead by Intermedics is a cardiac pacing lead used in conjunction with pacemakers to manage heart rhythm disorders. It is primarily used by cardiologists in hospital settings.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K844267 ↗
Decision Date ?
March 28, 1985
Product Code ?
DTB
Device Class ?
Class 3
Evidence ?
0 studies
The model 483-01 pacing lead was cleared through the FDA 510k pathway on March 28, 1985. Manufactured by Intermedics, it is classified as a Class III device under product code DTB.
What It Is
The model 483-01 pacing lead is a medical device designed to deliver electrical impulses from a pacemaker to the heart muscle, ensuring proper heart rhythm. It is typically inserted transvenously and positioned within the heart chambers. The lead is essential for patients with arrhythmias who require consistent cardiac pacing.
FDA-Cleared Indications
- Use with an implanted pacemaker system to provide cardiac pacing for patients with symptomatic bradycardia or heart block.
- Deliver electrical stimulation to the heart when intrinsic cardiac activity is inadequate or unreliable.
Clinical Applications
- Transvenous implantation as part of a permanent pacemaker procedure.
- Cardiac pacing for adults with clinically significant slow heart rhythms.
- Pacing support for patients with atrioventricular conduction disorders, including heart block.
Practical Considerations
- The lead is implanted through a venous access site and advanced under fluoroscopic imaging into a cardiac chamber; the specific access route and final position depend on the pacing system and clinical plan.
- Compatibility must be confirmed with the intended pacemaker generator, connector, lead configuration, and electrical specifications before implantation.
- Proper lead sizing, fixation, positioning, and electrical testing are important to reduce risks such as dislodgement, poor sensing, or inadequate pacing thresholds.
- MRI safety cannot be determined from the device name alone. Because this is an older pacing lead, clinicians should verify the complete implanted system and current manufacturer and FDA labeling before any MRI examination.
- Potential complications include infection, bleeding, venous injury or thrombosis, cardiac perforation, pneumothorax, lead dislodgement, malfunction, and the need for revision or replacement.
Frequently Asked Questions
What is the model 483-01 pacing lead used for?
It is used to deliver electrical impulses from a pacemaker to the heart, ensuring proper heart rhythm in patients with arrhythmias.
What specialties typically use this device?
Cardiologists and electrophysiologists typically use this device during pacemaker implantation procedures.
What are the FDA-cleared indications?
The pacing lead is indicated for use in patients with heart rhythm disorders such as bradycardia, where it helps maintain an adequate heart rate.
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.