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model 432-01 biopore implantable pacing lead
Intermedics
Summary: The Model 432-01 Biopore Implantable Pacing Lead is a medical device used for cardiac pacing. It is typically used by cardiologists to manage patients with heart rhythm disorders.
FDA Clearance Information
Pathway
510K
Number
K862053 ↗
Decision Date
September 19, 1986
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The Model 432-01 Biopore Implantable Pacing Lead was cleared via the FDA 510(k) pathway on September 19, 1986. Manufactured by Intermedics, it is classified as a Class III device.
What It Is
The Model 432-01 Biopore Implantable Pacing Lead is a specialized lead used in cardiac pacing systems. It is designed to be implanted into the heart to deliver electrical impulses that regulate heart rhythm. The lead features a biopore design, which enhances tissue integration and stability within the cardiac tissue.
Clinical Applications
This pacing lead is commonly used in procedures involving the implantation of pacemakers. It is primarily used by cardiologists and electrophysiologists in hospital settings. The device is suitable for patients with conditions such as bradycardia or other arrhythmias requiring pacing support.
Indications for Use
The FDA indications suggest this device is intended for patients who require cardiac pacing due to heart rhythm disorders. It is suitable for individuals with conditions like slow heart rate or irregular heartbeats.
Practical Considerations
When considering the Model 432-01, clinicians should note its compatibility with various pacemaker generators. The lead's design may offer advantages in terms of ease of implantation and long-term stability. Proper sizing and placement technique are crucial for optimal performance.
Frequently Asked Questions
What is the Model 432-01 Biopore Implantable Pacing Lead used for?
It is used for cardiac pacing to manage heart rhythm disorders.
What specialties typically use this device?
Cardiologists and electrophysiologists typically use this device.
What are the FDA-cleared indications?
The device is indicated for patients needing 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.