đź“‹ FDA Reference
smartablate system interface cable d-1303-02-s
Biosense Webster
Summary: The SmartAblate System Interface Cable by Biosense Webster is a component of the SmartAblate system used in tumor ablation procedures. It is primarily utilized by interventional radiologists and oncologists.
FDA Clearance Information
Pathway
PMA
Number
P990071 ↗
Decision Date
September 15, 2025
Product Code
LPB
Device Class
Class 3
Evidence
0 studies
The SmartAblate System Interface Cable, manufactured by Biosense Webster, received FDA clearance via PMA P990071 on September 15, 2025. It is classified as a Class 3 medical device.
What It Is
The SmartAblate System Interface Cable is a crucial component of the SmartAblate system, designed to facilitate the connection between various system elements during tumor ablation procedures. It ensures reliable transmission of signals and power, which is essential for the precise control of ablation energy delivery. This cable is engineered to meet the high standards required for medical procedures, ensuring safety and efficacy.
Clinical Applications
This device is commonly used in interventional oncology settings for the ablation of tumors. It is particularly relevant in procedures involving liver, kidney, or lung tumors, where precise ablation is critical. The device is typically used in hospitals and specialized cancer treatment centers, where it supports oncologists and interventional radiologists in performing minimally invasive tumor ablation.
Indications for Use
The FDA indication for this device is as an alternative subassembly manufacturer for the SmartAblate System Interface Cable. Clinically, this means it is used in procedures requiring tumor ablation, providing a reliable connection for the ablation system.
Practical Considerations
The SmartAblate System Interface Cable is designed for compatibility with the SmartAblate system. Clinicians should ensure that the cable is properly connected and secured to prevent signal loss during procedures. It is important to follow manufacturer guidelines for installation and maintenance to ensure optimal performance.
Frequently Asked Questions
What is the SmartAblate System Interface Cable used for?
It is used to connect components of the SmartAblate system during tumor ablation procedures, ensuring reliable signal and power transmission.
What specialties typically use this device?
Interventional radiologists and oncologists primarily use this device in tumor ablation procedures.
What are the FDA-cleared indications?
The device is indicated as an alternative subassembly manufacturer for the SmartAblate System Interface Cable, used in tumor ablation procedures.
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.