📋 FDA Reference
Intermedics Polyflex-Model 483-03 Lead
Intermedics
Summary: The Intermedics Polyflex-Model 483-03 Lead is a cardiac pacing lead used in conjunction with pacemakers. It is primarily utilized by cardiologists and electrophysiologists to manage arrhythmias.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K812990 ↗
Decision Date ?
November 16, 1981
Product Code ?
DTB
Device Class ?
Class 3
Evidence ?
0 studies
The Intermedics Polyflex-Model 483-03 Lead was cleared via the FDA 510(k) pathway on November 16, 1981. Manufactured by Intermedics, it is classified as a Class III device.
What It Is
The Intermedics Polyflex-Model 483-03 Lead is a flexible, insulated wire used to connect a pacemaker to the heart muscle. It transmits electrical impulses from the pacemaker to the heart to regulate heartbeats. This lead is designed for durability and reliable performance in long-term cardiac pacing therapy.
FDA-Cleared Indications
- Use with a compatible pacemaker system for chronic cardiac pacing.
- Use in patients requiring pacing for bradycardia or atrioventricular conduction block.
Clinical Applications
- Transvenous implantation as part of a permanent pacemaker system.
- Delivery of pacing impulses to the heart in patients with symptomatic slow heart rates.
- Pacing support for patients with atrioventricular block or other conduction disorders requiring permanent pacing.
Practical Considerations
- The lead must be matched to a compatible pacemaker generator and connector configuration.
- Lead length and positioning should be selected according to the patient's anatomy and the intended cardiac chamber.
- Implantation requires fluoroscopic or other appropriate imaging guidance, electrical testing, and confirmation of stable lead position.
- The supplied record does not establish MRI compatibility; MRI should not be performed unless the complete implanted system is specifically documented as MRI-conditional.
- Potential complications include lead displacement, fracture, insulation failure, infection, venous thrombosis, perforation, and abnormal pacing or sensing.
Frequently Asked Questions
What is the Intermedics Polyflex-Model 483-03 Lead used for?
It is used for cardiac pacing in patients with arrhythmias such as bradycardia or heart block.
What specialties typically use this device?
Cardiologists and electrophysiologists typically use this device in cardiac pacing procedures.
What are the FDA-cleared indications?
The lead is indicated for patients requiring 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.