📋 FDA Reference
Cordis Dual-Chamber Psa Model 296a Pacemaker
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 ?
510(k)
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.
FDA-Cleared Indications
- Use in patients with symptomatic bradycardia requiring artificial pacing.
- Use in patients with atrioventricular conduction disturbances, including heart block, requiring pacing.
- Use when electrical pacing is needed to maintain an adequate heart rate.
Clinical Applications
- Dual-chamber pacing of the right atrium and right ventricle.
- Treatment of symptomatic slow heart rates caused by impaired cardiac conduction.
- Pacing support for patients with atrioventricular block.
- Implantation with compatible atrial and ventricular leads when coordinated chamber pacing is clinically indicated.
Practical Considerations
- The Model 296A is an older device cleared in 1985; clinicians should verify the original labeling, current availability, and device-specific technical documentation before use.
- Lead type, connector compatibility, sensing and pacing thresholds, and generator-lead matching must be confirmed before implantation or replacement.
- MRI safety cannot be assumed. This legacy pacemaker should be treated as not MR conditional unless official documentation confirms otherwise; abandoned or incompatible leads may add risk.
- Implantation requires assessment of venous access, cardiac anatomy, infection risk, and the patient's ability to undergo the procedure and follow-up.
- Battery longevity depends on programmed settings, pacing burden, lead performance, and device condition; interrogation is required to estimate remaining service life.
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.