📋 FDA Reference
Model 492-01 Pacemaker Lead
Intermedics
Summary: The model 492-01 pacemaker lead by Intermedics is a cardiac device used to deliver electrical impulses to the heart. It is primarily used by cardiologists for patients requiring cardiac pacing.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K813136 ↗
Decision Date ?
April 3, 1985
Product Code ?
DTB
Device Class ?
Class 3
Evidence ?
0 studies
This device was cleared through the FDA 510k pathway on April 3, 1985. It is manufactured by Intermedics and classified as a Class III device under product code DTB.
What It Is
The model 492-01 pacemaker lead is an implantable device designed to transmit electrical impulses from a pacemaker to the heart muscle, ensuring proper heart rhythm. It consists of a flexible wire that connects to the pacemaker and is inserted into the heart's chambers, typically the right atrium or ventricle. This lead is crucial for patients with arrhythmias or heart block who require consistent cardiac pacing.
FDA-Cleared Indications
- Use in patients who require electrical pacing of the heart.
- Use for cardiac rhythm disorders associated with heart block or a slow heart rate.
Clinical Applications
- Connecting an implanted pacemaker generator to the right atrium or right ventricle for cardiac pacing.
- Providing long-term pacing for patients with symptomatic bradycardia.
- Providing pacing for patients with atrioventricular or other clinically significant heart block.
- Use during implantation or replacement of a pacemaker system when a compatible lead is required.
Practical Considerations
- The lead must be compatible with the selected pacemaker generator and the intended pacing system.
- Lead length, fixation method, connector configuration, and pacing chamber must match the patient's anatomy and the generator specifications.
- Implantation requires fluoroscopic or other appropriate imaging guidance, sterile technique, and testing of sensing, pacing thresholds, and lead integrity.
- MRI safety cannot be determined from the FDA record provided. The lead and the complete implanted system should be treated as not established as MRI-conditional unless current manufacturer labeling confirms otherwise.
- Patients require ongoing device follow-up to assess lead position, electrical performance, insulation integrity, and battery-generator function.
Frequently Asked Questions
What is the model 492-01 pacemaker lead used for?
It is used to deliver electrical impulses to the heart to maintain a regular heart rhythm in patients with arrhythmias.
What specialties typically use this device?
Cardiologists, particularly those specializing in electrophysiology and interventional cardiology, typically use this device.
What are the FDA-cleared indications?
The device is indicated for patients requiring cardiac pacing due to conditions like heart block or symptomatic 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.