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cordis dual-chamber psa model 296a pacemaker
Cordis
Summary: The Cordis Dual-Chamber PSA Model 296A Pacemaker is a device used to regulate heart rhythms in patients with arrhythmias. It is primarily used by cardiologists in hospital settings.
FDA Clearance Information
Pathway
510K
Number
K844969 ↗
Decision Date
May 1, 1985
Product Code
DTC
Device Class
Class 2
Evidence
0 studies
The Cordis Dual-Chamber PSA Model 296A Pacemaker was cleared via the FDA 510k pathway on May 1, 1985. It is manufactured by Cordis and classified as a Class 2 medical device.
What It Is
The Cordis Dual-Chamber PSA Model 296A Pacemaker is a medical device designed to manage abnormal heart rhythms by delivering electrical impulses to the heart. It features dual-chamber pacing, which allows for coordinated pacing of both the atrium and ventricle, improving cardiac output and patient outcomes. This device is typically implanted in patients with conditions such as bradycardia or heart block.
Clinical Applications
This pacemaker is commonly used in cardiology, particularly for patients with symptomatic bradycardia or atrioventricular block. It is typically implanted in a hospital setting by a cardiologist or electrophysiologist. The device is suitable for a wide range of patients, including those with heart failure or post-myocardial infarction complications, who require pacing support.
Indications for Use
The FDA indications for this pacemaker include its use in patients with arrhythmias that result in slow heart rates, such as bradycardia or heart block. It is intended for individuals who need assistance in maintaining an adequate heart rate.
Practical Considerations
When considering implantation, clinicians should assess the patient's anatomy and the device's compatibility with existing cardiac structures. The device is typically available in various lead configurations to accommodate different patient needs and anatomical considerations.
Frequently Asked Questions
What is the Cordis Dual-Chamber PSA Model 296A Pacemaker used for?
It is used to manage abnormal heart rhythms by delivering electrical impulses to the heart, particularly in patients with bradycardia or heart block.
What specialties typically use this device?
Cardiologists and electrophysiologists primarily use this device in hospital settings.
What are the FDA-cleared indications?
The device is indicated for patients with arrhythmias that cause slow heart rates, such as bradycardia or heart block, to help maintain an adequate heart rate.
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.