📋 FDA Reference
Model 492-01 Pacing Lead
Intermedics
Summary: The model 492-01 pacing lead is a cardiac device used to deliver electrical impulses to the heart. It is primarily used by cardiologists in patients requiring cardiac pacing.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K844266 ↗
Decision Date ?
March 28, 1985
Product Code ?
DTB
Device Class ?
Class 3
Evidence ?
0 studies
The model 492-01 pacing lead by Intermedics was cleared through the FDA 510k pathway on March 28, 1985. It is a Class III device under product code DTB.
What It Is
The model 492-01 pacing lead is a medical device designed to deliver electrical impulses to the heart to maintain an adequate heart rate. It is typically used in conjunction with a pacemaker. The lead is inserted into the heart via a vein and positioned to ensure optimal pacing. This device is crucial for patients with arrhythmias or heart block who require consistent cardiac pacing.
FDA-Cleared Indications
- Electrical pacing of the heart in patients who require cardiac pacing support.
- Use with a compatible pacemaker system to help maintain an adequate heart rate.
Clinical Applications
- Connecting a pacemaker generator to the heart for cardiac pacing.
- Pacing patients with bradycardia or clinically significant slow heart rhythms.
- Pacing patients with heart block who require an implanted pacing system.
- Placement through a vein into a cardiac chamber under imaging and electrophysiologic guidance.
Practical Considerations
- The lead must be matched to a compatible pacemaker generator and connector system; compatibility should be confirmed before implantation.
- Lead length and configuration should be selected for the patient's anatomy and intended cardiac chamber.
- Secure fixation and careful positioning are important to reduce dislodgement, poor sensing, or ineffective pacing.
- The available FDA record does not establish that this specific legacy lead is MRI safe or MRI conditional. MRI eligibility should be verified from the original labeling and the complete implanted system.
- Potential complications include infection, bleeding, venous injury, lead dislodgement, lead fracture, loss of capture, and arrhythmia. Implantation is performed by qualified cardiac specialists.
Frequently Asked Questions
What is the model 492-01 pacing lead used for?
It is used to deliver electrical impulses to the heart in patients requiring cardiac pacing.
What specialties typically use this device?
Cardiology and cardiac surgery specialties typically use this device.
What are the FDA-cleared indications?
It is indicated for patients needing electrical pacing of the heart, such as those with 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.