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pacing lead models sa 350 sam 500
R.E. Brown
Summary: The pacing lead models SA 350 and SAM 500 by R.E. Brown are used in cardiac pacing systems to deliver electrical impulses to the heart. These devices are typically used by cardiologists in hospital settings for patients with arrhythmias.
FDA Clearance Information
Pathway
510K
Number
K781619 ↗
Decision Date
December 8, 1978
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The pacing lead models SA 350 and SAM 500 were cleared through the FDA 510(k) pathway on December 8, 1978. Manufactured by R.E. Brown, these devices are classified as Class III under product code DTB.
What It Is
The pacing lead models SA 350 and SAM 500 are components of cardiac pacing systems designed to deliver electrical impulses to the heart muscle, ensuring proper heart rhythm. These leads are implanted into the heart and connected to a pacemaker device, which regulates the heartbeat in patients with arrhythmias. Their design facilitates reliable electrical conduction and stable implantation within the cardiac tissue.
Clinical Applications
These pacing leads are primarily used in the management of patients with bradycardia or other arrhythmias requiring electrical pacing. Cardiologists typically implant these devices during procedures in hospital cardiac units. They are suitable for a wide range of patients, including those with heart block or sick sinus syndrome, and are integral to maintaining adequate heart rates in these populations.
Indications for Use
The pacing leads are indicated for patients who require cardiac pacing due to arrhythmias such as bradycardia. They are used to ensure that the heart maintains a regular rhythm and adequate rate, particularly in conditions where the heart's natural pacemaker is not functioning properly.
Practical Considerations
When selecting pacing leads, clinicians should consider the size and compatibility with the patient's anatomy and the pacemaker device. Proper implantation technique is crucial to ensure lead stability and effective pacing. Regular follow-up is necessary to monitor lead function and patient response.
Frequently Asked Questions
What is pacing lead models SA 350 SAM 500 used for?
These pacing leads are used to deliver electrical impulses to the heart in patients with arrhythmias, ensuring a regular heart rhythm.
What specialties typically use this device?
Cardiologists and electrophysiologists typically use these devices in hospital settings, particularly in cardiac units.
What are the FDA-cleared indications?
These leads are indicated for patients requiring cardiac pacing due to arrhythmias such as bradycardia.
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.