📋 FDA Reference
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 ?
510(k)
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.
FDA-Cleared Indications
- Use with a compatible pacemaker system to provide cardiac pacing.
- Treatment of patients with rhythm disorders requiring electrical stimulation of the heart, including bradycardia, when indicated by the pacemaker system labeling.
Clinical Applications
- Transvenous placement of a cardiac pacing lead during pacemaker implantation.
- Delivery of pacing impulses to a cardiac chamber through connection to a compatible pacemaker.
- Long-term cardiac pacing in appropriately selected patients with a labeled indication for pacemaker therapy.
Practical Considerations
- The lead must be matched to a compatible pacemaker generator and connector system.
- Available lead lengths and configuration details should be confirmed in the original product labeling and implant records.
- Placement requires imaging and electrical testing to confirm appropriate position, sensing, pacing threshold, and lead stability.
- This is an older device record; MRI compatibility should not be assumed. The complete implanted system must be evaluated before MRI.
- Potential complications include lead dislodgement, loss of capture or sensing, infection, venous thrombosis, cardiac perforation, and device malfunction.
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.