📋 FDA Reference
Model 490-01 Pacing Lead
Intermedics
Summary: The Model 490-01 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 ?
K844261 ↗
Decision Date ?
March 28, 1985
Product Code ?
DTB
Device Class ?
Class 3
Evidence ?
0 studies
The Model 490-01 pacing lead was cleared through the FDA 510(k) pathway on March 28, 1985. Manufactured by Intermedics, it is classified as a Class III device.
What It Is
The Model 490-01 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, which generates the electrical signals. The lead is inserted into the heart via a vein and secured in place to ensure consistent electrical conduction.
FDA-Cleared Indications
- Use as a cardiac pacing lead with a compatible pacemaker system when cardiac pacing is clinically indicated.
- Use to deliver electrical stimulation to the heart in patients requiring treatment for bradycardia or other labeled indications for cardiac pacing.
Clinical Applications
- Permanent pacemaker implantation for patients who require treatment for bradycardia.
- Transvenous placement of a pacing lead in a cardiac chamber as part of a pacemaker system.
- Delivery of electrical impulses from an implanted pulse generator to the heart.
Practical Considerations
- The lead is placed through a venous access site and advanced under imaging and intracardiac electrical testing to the intended cardiac position.
- Available lead lengths and specifications should be matched to the patient's anatomy and the compatible pacemaker generator.
- Potential complications include lead dislodgement, failure to capture, abnormal sensing, venous injury, cardiac perforation, arrhythmia, thrombosis and infection.
- MRI safety cannot be determined from the device record alone. The lead and the complete pacemaker system must be evaluated against the applicable MRI-conditional labeling; older systems may not be MRI compatible.
- The lead should not be used when the patient has a contraindication to transvenous lead placement or when the lead cannot be connected to a compatible pulse generator.
Frequently Asked Questions
What is the Model 490-01 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?
Cardiologists and electrophysiologists typically use this device in clinical settings.
What are the FDA-cleared indications?
The device is indicated for patients needing cardiac pacing due to conditions like bradycardia.
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.