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fastpass implantable endocard pacing
Pacesetter Systems
Summary: The Fastpass Implantable Endocard Pacing device is used for cardiac pacing in patients with arrhythmias. It is typically utilized by cardiologists in hospital settings.
FDA Clearance Information
Pathway
510K
Number
K821947 ↗
Decision Date
August 6, 1982
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The Fastpass Implantable Endocard Pacing device was cleared through the FDA 510(k) pathway on August 6, 1982. Manufactured by Pacesetter Systems, it is classified as a Class III device.
What It Is
The Fastpass Implantable Endocard Pacing device is an implantable cardiac pacemaker designed to regulate heart rhythms in patients with arrhythmias. It works by delivering electrical impulses to the heart to maintain an appropriate heart rate. This device is crucial for patients with bradycardia or other conditions that cause the heart to beat too slowly.
Clinical Applications
This device is commonly used in cardiology, particularly in electrophysiology labs and cardiac surgery settings. It is indicated for patients with symptomatic bradycardia, atrioventricular block, or other conduction disorders. The device is typically implanted in adults but can be adapted for pediatric use in specialized cases.
Indications for Use
The Fastpass Implantable Endocard Pacing device is indicated for patients who require assistance in maintaining a regular heart rhythm. This includes individuals with slow heart rates or those who experience heart block.
Practical Considerations
When considering the Fastpass device, clinicians should be aware of its compatibility with existing leads and the need for periodic battery replacement. Proper sizing and placement are crucial for optimal performance and patient comfort.
Frequently Asked Questions
What is the Fastpass Implantable Endocard Pacing used for?
It is used to regulate heart rhythms in patients with arrhythmias, particularly those with slow heart rates or heart block.
What specialties typically use this device?
Cardiologists, especially those specializing in electrophysiology and cardiac surgery, commonly use this device.
What are the FDA-cleared indications?
The device is indicated for patients needing cardiac pacing due to arrhythmias such as 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.