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electrode pacemaker perm temp
Vitatron Medical
Summary: The electrode pacemaker perm temp by Vitatron Medical is a cardiac device used to regulate heart rhythms. It is primarily used by cardiologists for patients with arrhythmias.
FDA Clearance Information
Pathway
510K
Number
K840668 ↗
Decision Date
September 24, 1984
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
This device was cleared through the FDA 510k pathway on September 24, 1984. It is manufactured by Vitatron Medical and classified as a Class III device.
What It Is
The electrode pacemaker perm temp is a cardiac device designed to manage abnormal heart rhythms. It works by delivering electrical impulses to the heart muscle to ensure a regular heartbeat. This device is crucial for patients with conditions such as bradycardia, where the heart beats too slowly.
Clinical Applications
This pacemaker is commonly used in cardiology, particularly in settings like hospitals and specialized cardiac care units. It is suitable for patients with arrhythmias, including those who have experienced heart block or sick sinus syndrome. The device can be used in both temporary and permanent pacing scenarios.
Indications for Use
The FDA indications suggest this device is for patients with heart rhythm disorders that require electrical pacing. It is typically used in individuals who experience slow heart rates or irregular heartbeats.
Practical Considerations
Clinicians should consider the compatibility of the pacemaker with existing cardiac devices. Proper sizing and placement are crucial for optimal performance. Familiarity with the implantation technique is essential for successful outcomes.
Related Literature
The linked study reviewed outcomes of primary leadless pacemaker implantation, highlighting their growing use as an alternative to traditional pacemakers. Key findings suggest leadless pacemakers are effective, but data on emergency implantation is limited. The study underscores the need for further research in acute settings.
Frequently Asked Questions
What is the electrode pacemaker perm temp used for?
It is used to manage abnormal heart rhythms by providing electrical stimulation to maintain a regular heartbeat.
What specialties typically use this device?
Cardiologists and electrophysiologists commonly use this device in cardiac care settings.
What are the FDA-cleared indications?
It is indicated for patients with heart rhythm disorders such as bradycardia or heart block requiring pacing.
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.