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model 436-01 biopore implantable pacing lead
Intermedics
Summary: The Model 436-01 Biopore Implantable Pacing Lead is used in cardiac pacing systems to deliver electrical impulses to the heart. It is primarily used by cardiologists and electrophysiologists in patients requiring cardiac rhythm management.
FDA Clearance Information
Pathway
510K
Number
K862051 ↗
Decision Date
January 6, 1987
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The Model 436-01 Biopore Implantable Pacing Lead was cleared through the FDA 510(k) pathway on January 6, 1987. Manufactured by Intermedics, it is classified as a Class III device under product code DTB.
What It Is
The Model 436-01 Biopore Implantable Pacing Lead is a medical device designed to transmit electrical impulses from a pacemaker to the heart muscle, ensuring proper heart rhythm. It features a biopore design that enhances tissue in-growth, promoting stability and reducing the risk of lead dislodgement. This lead is typically implanted via a transvenous approach and is compatible with various pacemaker models.
Clinical Applications
This pacing lead is commonly used in patients with bradycardia or other arrhythmias requiring pacemaker intervention. It is utilized in settings such as hospitals and specialized cardiac centers, primarily by cardiologists and electrophysiologists. The device is suitable for adult patients who require long-term cardiac pacing support.
Indications for Use
The FDA indications suggest that this device is intended for patients who need cardiac pacing due to arrhythmias like bradycardia. It is specifically designed for use in individuals who require reliable and stable lead placement for effective cardiac rhythm management.
Practical Considerations
The Model 436-01 lead is available in various lengths to accommodate different patient anatomies and is designed to be compatible with a range of pacemakers. Clinicians should be aware of the implantation technique and ensure proper lead positioning to optimize device performance and patient outcomes.
Frequently Asked Questions
What is the Model 436-01 Biopore Implantable Pacing Lead used for?
It is used to deliver electrical impulses from a pacemaker to the heart to manage arrhythmias such as bradycardia.
What specialties typically use this device?
Cardiologists and electrophysiologists typically use this device in cardiac rhythm management procedures.
What are the FDA-cleared indications?
The device is indicated for patients requiring cardiac pacing due to arrhythmias like bradycardia, ensuring stable and effective heart rhythm management.
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.