📋 FDA Reference
Afp Cardiac Pacing System Model 283
Siemens-Pacesetter
Summary: The AFP Cardiac Pacing System Model 283 is a dual-chamber pacemaker used to manage arrhythmias. It is primarily used by cardiologists for patients with heart rhythm disorders.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K942440 ↗
Decision Date ?
August 8, 1994
Product Code ?
DTB
Device Class ?
Class 3
Evidence ?
0 studies
The AFP Cardiac Pacing System Model 283, manufactured by Siemens-Pacesetter, was cleared through the FDA 510k pathway on August 8, 1994. It is a Class III medical device.
What It Is
The AFP Cardiac Pacing System Model 283 is a dual-chamber pacemaker designed to regulate heart rhythms by delivering electrical impulses to the heart. It features both atrial and ventricular leads, allowing for atrioventricular sequential pacing. This system helps maintain appropriate heart rates in patients with bradycardia or other arrhythmias.
FDA-Cleared Indications
- Pacing support for symptomatic bradycardia caused by atrioventricular block.
- Pacing support for sinus node dysfunction, including sick sinus syndrome.
- Dual-chamber atrioventricular sequential pacing when both atrial and ventricular sensing or pacing are clinically required.
Clinical Applications
- Treatment of slow heart rates associated with atrioventricular conduction block.
- Treatment of symptomatic sinus node dysfunction or sick sinus syndrome.
- Maintenance of an appropriate heart rate using atrial and ventricular pacing.
- Implantation with compatible unipolar or bipolar pacing leads in patients who require permanent pacing support.
Practical Considerations
- The system uses separate atrial and ventricular leads for dual-chamber pacing.
- The device is compatible with unipolar and bipolar leads; lead selection and placement depend on patient anatomy and the clinical pacing plan.
- The generator is typically placed beneath the skin of the upper chest, with leads advanced through a venous access site into the right atrium and right ventricle.
- MRI safety should not be assumed. This older pacemaker system and its leads should be evaluated against the specific labeling and institutional MRI protocol before scanning.
- Contraindications, lead compatibility, battery status, and programming requirements should be reviewed in the current manufacturer documentation before implantation or follow-up.
Related Literature
The linked study investigated myopotential interference in DDD-mode pacemakers, including the AFP models 281 and 283. It found that skeletal muscle activity could affect pacemaker function, leading to arrhythmias in some patients. The study highlighted the importance of monitoring for myopotential interference but was limited by a small sample size.
Frequently Asked Questions
What is the AFP Cardiac Pacing System Model 283 used for?
It is used to manage arrhythmias by providing electrical pacing to the heart, particularly in patients with slow heart rhythms.
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 with conditions like heart block or sinus node dysfunction that cause slow heart rhythms.
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.