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pacing lead pma f 860
Ela Medical
Summary: The pacing lead PMA F 860 by Ela Medical is a cardiac device used in pacing systems to deliver electrical impulses to the heart. It is primarily used by cardiologists in patients requiring cardiac pacing.
FDA Clearance Information
Pathway
510K
Number
K830457 ↗
Decision Date
March 17, 1983
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The pacing lead PMA F 860 was cleared through the FDA 510k pathway on March 17, 1983. It is manufactured by Ela Medical and classified as a Class III device.
What It Is
The pacing lead PMA F 860 is an implantable lead used in cardiac pacing systems. It is designed to deliver electrical impulses from a pacemaker to the heart muscle, helping to maintain an adequate heart rate in patients with arrhythmias. The lead is typically inserted transvenously and positioned in the heart under fluoroscopic guidance.
Clinical Applications
This device is commonly used in cardiology, particularly in electrophysiology and cardiac surgery settings. It is indicated for patients with bradycardia or other arrhythmias that require pacing support. The device is used in both inpatient and outpatient settings, often in patients with heart block or sick sinus syndrome.
Indications for Use
The pacing lead is indicated for patients who require cardiac pacing due to conditions like heart block or bradycardia. It is suitable for individuals who need long-term pacing support to maintain a regular heart rhythm.
Practical Considerations
When considering the pacing lead PMA F 860, clinicians should note the typical lead length and compatibility with specific pacemaker models. Proper placement technique is crucial for optimal performance, and fluoroscopic guidance is recommended during insertion.
Frequently Asked Questions
What is pacing lead PMA F 860 used for?
It is used to deliver electrical impulses to the heart in patients requiring cardiac pacing.
What specialties typically use this device?
Cardiologists, particularly those specializing in electrophysiology and cardiac surgery, commonly use this device.
What are the FDA-cleared indications?
The device is indicated for patients with arrhythmias requiring pacing support, such as those with 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.