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intermedics polyflex pacing lead 480-01
Intermedics
Summary: The Intermedics Polyflex Pacing Lead 480-01 is a cardiac pacing lead used in conjunction with pacemakers to manage arrhythmias. It is primarily used by cardiologists in hospital settings.
FDA Clearance Information
Pathway
510K
Number
K820267 ↗
Decision Date
April 3, 1985
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The Intermedics Polyflex Pacing Lead 480-01 was cleared through the FDA 510k pathway on April 3, 1985. It is manufactured by Intermedics and classified as a Class III medical device.
What It Is
The Intermedics Polyflex Pacing Lead 480-01 is a flexible lead designed for use with pacemakers to deliver electrical impulses to the heart. It is typically inserted transvenously and positioned within the heart chambers to ensure effective pacing. The lead is constructed to provide reliable electrical conduction and durability within the cardiac environment.
Clinical Applications
This pacing lead is commonly used in patients with bradycardia or other arrhythmias requiring pacemaker intervention. Cardiologists and electrophysiologists typically use this device in hospital settings, particularly in cardiac catheterization labs or during electrophysiology procedures. It is suitable for adult patients who require long-term cardiac pacing.
Indications for Use
The FDA indications suggest this device is used for patients who need cardiac pacing due to arrhythmias such as bradycardia. It helps maintain an adequate heart rate by delivering electrical impulses to stimulate heart contractions.
Practical Considerations
The Intermedics Polyflex Pacing Lead 480-01 is available in various lengths to accommodate different patient anatomies. It is compatible with a range of pacemaker devices. Clinicians should ensure proper placement and secure fixation to minimize lead dislodgement.
Frequently Asked Questions
What is the Intermedics Polyflex Pacing Lead 480-01 used for?
It is used for cardiac pacing in patients with arrhythmias such as bradycardia.
What specialties typically use this device?
Cardiologists and electrophysiologists typically use this device.
What are the FDA-cleared indications?
The device is indicated for use in patients requiring cardiac pacing due to arrhythmias.
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.