📋 FDA Reference
Endocardial Pacing Lead Model 476-01
Intermedics
Summary: The endocardial pacing lead model 476-01 by Intermedics is a device used in cardiac pacing procedures. It is primarily used by cardiologists to manage arrhythmias in patients requiring pacemaker implantation.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K790548 ↗
Decision Date ?
June 1, 1979
Product Code ?
DTB
Device Class ?
Class 3
Evidence ?
0 studies
The endocardial pacing lead model 476-01 was cleared through the FDA 510k pathway on June 1, 1979. Manufactured by Intermedics, it is classified as a Class III device under product code DTB.
What It Is
The endocardial pacing lead model 476-01 is a cardiac device designed to deliver electrical impulses to the heart muscle, ensuring proper heart rhythm in patients with arrhythmias. It is implanted within the heart's endocardial surface and connects to a pacemaker. The lead facilitates the transmission of electrical signals from the pacemaker to the heart, helping to maintain an adequate heart rate.
FDA-Cleared Indications
- Cardiac pacing in patients who require electrical stimulation because of an inadequate intrinsic heart rate.
- Use with a compatible pacemaker system when pacing support is clinically indicated.
- Endocardial placement to transmit pacing impulses between the pacemaker generator and the heart.
Clinical Applications
- Transvenous implantation during permanent pacemaker placement.
- Pacing support for clinically significant bradycardia when a pacemaker is indicated.
- Pacing support for heart block or other cardiac conduction disorders requiring permanent pacing.
- Connection of an implanted pacemaker generator to the endocardial surface of the heart.
Practical Considerations
- Confirm electrical, mechanical, and connector compatibility with the selected pacemaker generator before implantation.
- The lead requires careful handling, appropriate sizing, and accurate endocardial positioning under fluoroscopic and electrophysiologic assessment.
- Review the original device labeling before MRI exposure; MRI safety cannot be assumed for this older lead or for a pacemaker system containing it.
- Potential contraindications and precautions include active infection, unsuitable venous access, and inability to safely position or secure the lead.
- Long-term performance depends on lead integrity, fixation, insulation, pacing thresholds, and follow-up testing.
Frequently Asked Questions
What is endocardial pacing lead model 476-01 used for?
It is used for cardiac pacing in patients with arrhythmias, ensuring proper heart rhythm.
What specialties typically use this device?
Cardiologists, particularly those specializing in electrophysiology, use this device in pacemaker implantation procedures.
What are the FDA-cleared indications?
It is indicated for patients needing cardiac pacing due to conditions like 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.