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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
510K
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.
Clinical Applications
This pacing lead is commonly used in the management of bradycardia, where the heart beats too slowly. It is typically employed in cardiology settings, including hospitals and specialized cardiac care centers. Patients who benefit from this device often have conditions such as sick sinus syndrome or atrioventricular block.
Indications for Use
The Polyflex 483-09 is indicated for patients requiring cardiac pacing due to conditions like slow heart rhythms or heart block. It is suitable for individuals who need long-term rhythm management.
Practical Considerations
The Polyflex 483-09 comes in various lengths to accommodate different patient anatomies and is compatible with most pacemaker generators. Proper lead placement and secure fixation are crucial for optimal performance and longevity.
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.