📋 FDA Reference
Model 483-02 Pacing Lead
Intermedics
Summary: The Model 483-02 pacing lead is a cardiac device used for pacing the heart. It is primarily utilized by cardiologists in patients requiring cardiac rhythm management.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K844269 ↗
Decision Date ?
March 28, 1985
Product Code ?
DTB
Device Class ?
Class 3
Evidence ?
0 studies
The Model 483-02 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 483-02 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 is crucial for patients with arrhythmias or heart block.
FDA-Cleared Indications
- Cardiac pacing in patients who require electrical stimulation to maintain an adequate heart rate.
- Use with a compatible pacemaker system for management of slow heart rhythms or heart block.
Clinical Applications
- Permanent transvenous cardiac pacing when a pacemaker is clinically indicated.
- Placement in the heart through a venous access route for delivery of pacing impulses.
- Pacing support for patients with bradycardia or heart block, as specified by the compatible pacing system labeling.
Practical Considerations
- Confirm compatibility with the intended pacemaker generator and the complete pacing system before implantation.
- Select an appropriate lead length and configuration for the patient's anatomy and the planned cardiac chamber.
- Placement requires fluoroscopic or other suitable imaging guidance and careful testing of electrical performance.
- MRI safety cannot be determined from this historical device record alone; verify the complete system's current MRI labeling before scanning.
- Assess for standard pacing-lead risks and contraindications, including infection, venous access problems, bleeding risk, lead dislodgement, perforation, and device malfunction.
Frequently Asked Questions
What is Model 483-02 pacing lead used for?
It is used for cardiac pacing in patients with arrhythmias or heart block to maintain a regular heart rate.
What specialties typically use this device?
Cardiologists, particularly those specializing in electrophysiology and cardiac surgery, commonly use this device.
What are the FDA-cleared indications?
The device is indicated for patients requiring cardiac pacing due to slow heart rhythms 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.