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permanent pacing pad modification
Oscor Medical
Summary: The permanent pacing pad modification by Oscor Medical is a device used in cardiac pacing procedures. It is primarily utilized by cardiologists and electrophysiologists to ensure effective pacing in patients requiring cardiac rhythm management.
FDA Clearance Information
Pathway
510K
Number
K915008 ↗
Decision Date
January 27, 1992
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The permanent pacing pad modification was cleared through the FDA 510k pathway on January 27, 1992. Manufactured by Oscor Medical, it is classified as a Class III device under product code DTB.
What It Is
The permanent pacing pad modification is a medical device designed to enhance the functionality of pacing systems used in cardiac procedures. It works by providing a stable interface for the delivery of electrical impulses to the heart, ensuring consistent pacing. This device is crucial for patients with arrhythmias or other cardiac rhythm disorders, where reliable pacing is necessary to maintain proper heart function.
Clinical Applications
This device is commonly used in settings such as cardiac catheterization labs and electrophysiology suites. It is particularly relevant in procedures involving permanent pacemaker implantation or modifications. Cardiologists and electrophysiologists use this device to manage patients with bradycardia or heart block, ensuring effective pacing therapy. It is suitable for adult and geriatric populations who require long-term cardiac rhythm management.
Indications for Use
The FDA-cleared indications for this device involve its use in patients requiring permanent cardiac pacing. It is intended for individuals with conditions like bradycardia or heart block, where consistent electrical stimulation of the heart is necessary to maintain an adequate heart rate.
Practical Considerations
Clinicians should consider the compatibility of the pacing pad with existing pacemaker systems. Proper sizing and placement are crucial for optimal performance. The device should be used in conjunction with standard pacing leads and systems, following established procedural protocols.
Related Literature
The linked study, 'Clinical Cohorts for Validation of New Digital Biomarkers,' explores the use of digital biomarkers in clinical settings. While specific details and findings are not available, the study likely focuses on validating new technologies in patient monitoring. Limitations include the lack of an abstract and publication year, which restricts the ability to fully assess its relevance to the pacing pad modification.
Frequently Asked Questions
What is the permanent pacing pad modification used for?
It is used to provide a stable interface for cardiac pacing systems, ensuring effective delivery of electrical impulses to the heart.
What specialties typically use this device?
Cardiologists and electrophysiologists commonly use this device in cardiac rhythm management procedures.
What are the FDA-cleared indications?
It is indicated for patients requiring permanent cardiac pacing, such as those with bradycardia or heart block.
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.