đź“‹ FDA Reference
Polyflex 483-09 Endocardial Implantable Pacinglead
Intermedics
Summary: The Polyflex 483-09 is an endocardial implantable pacing lead used in cardiac pacing systems. It is primarily utilized by cardiologists for patients requiring pacemaker implantation.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K854069 ↗
Decision Date ?
December 9, 1985
Product Code ?
DTB
Device Class ?
Class 3
Evidence ?
0 studies
The Polyflex 483-09 received FDA clearance via the 510k pathway on December 9, 1985. Manufactured by Intermedics, it is classified as a Class III medical device.
What It Is
The Polyflex 483-09 is an implantable pacing lead designed for use in cardiac pacemaker systems. It facilitates electrical conduction between the pacemaker and the heart muscle, ensuring proper heart rhythm management. The lead is typically inserted through a vein and positioned within the heart under fluoroscopic guidance.
FDA-Cleared Indications
- Use as an endocardial pacing lead in a cardiac pacemaker system when permanent cardiac pacing is indicated.
- Use for patients requiring pacing for bradycardia or atrioventricular conduction disorders, consistent with the device labeling and product code.
Clinical Applications
- Transvenous endocardial lead placement during permanent pacemaker implantation.
- Cardiac pacing for symptomatic slow heart rhythms.
- Pacing for atrioventricular block or other conduction disorders requiring a pacemaker.
- Connection between an implanted pacemaker generator and the heart's endocardial surface.
Practical Considerations
- The lead is inserted through a venous access site and advanced into the heart under fluoroscopic imaging.
- Available lead lengths and configurations should be matched to the patient's anatomy and the intended pacing chamber.
- The lead must be securely positioned and electrically tested before connection to a compatible pacemaker generator.
- MRI safety should not be assumed. This is an older lead, and MRI eligibility depends on the complete implanted system, labeling, and institutional protocols.
- Potential contraindications and complications include infection, venous or cardiac perforation, lead dislodgment, thrombosis, insulation or conductor failure, and inability to obtain acceptable pacing parameters.
Frequently Asked Questions
What is the Polyflex 483-09 Endocardial Pacing Lead used for?
It is used for cardiac pacing in patients with slow heart rhythms or heart block.
What specialties typically use this device?
Cardiologists and electrophysiologists typically use this device in cardiac care settings.
What are the FDA-cleared indications?
It 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.