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afp cardiac pacing system model 283 modification
Pacesetter
Summary: The AFP Cardiac Pacing System Model 283 is a dual-chamber pacemaker used for cardiac pacing in patients with arrhythmias. It is primarily used by cardiologists in hospital settings.
FDA Clearance Information
Pathway
510K
Number
K954714 ↗
Decision Date
February 1, 1996
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The AFP Cardiac Pacing System Model 283 was cleared through the FDA 510(k) process on February 1, 1996. It is manufactured by Pacesetter and classified as a Class III medical device.
What It Is
The AFP Cardiac Pacing System Model 283 is a dual-chamber pacemaker designed to provide electrical stimulation to the heart in patients with arrhythmias. It features both atrial and ventricular leads to support atrioventricular sequential pacing, which helps maintain proper heart rhythm. This device is particularly useful in managing conditions like heart block or sick sinus syndrome.
Clinical Applications
This pacemaker is commonly used in cardiology for patients experiencing symptomatic bradycardia or heart block. It is typically implanted in a hospital setting by electrophysiologists or cardiologists. The device is suitable for a wide range of patients, including those with complex arrhythmias requiring precise pacing control.
Indications for Use
The device is indicated for patients who require pacing support due to arrhythmias such as atrioventricular block or sick sinus syndrome. It helps maintain adequate heart rate and rhythm in these patients.
Practical Considerations
The AFP Cardiac Pacing System Model 283 is compatible with standard pacing leads and is typically implanted using a minimally invasive surgical procedure. Clinicians should ensure proper lead placement and device programming to optimize patient outcomes.
Related Literature
The linked study investigated myopotential interference in DDD-mode pacemakers, including the AFP models 281 and 283. It found that skeletal myopotentials could inhibit pacemaker output, leading to arrhythmias in some patients. The study highlighted the importance of monitoring and managing such interference, though it was limited by a small sample size.
Frequently Asked Questions
What is AFP Cardiac Pacing System Model 283 used for?
It is used for cardiac pacing in patients with arrhythmias such as atrioventricular block or sick sinus syndrome.
What specialties typically use this device?
Cardiologists and electrophysiologists typically use this device in hospital settings.
What are the FDA-cleared indications?
The device is indicated for patients requiring pacing support due to arrhythmias like atrioventricular block or sick sinus syndrome.
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.