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.
FDA-Cleared Indications
- Alternative subassembly manufacturer for the SmartAblate System Interface Cable (D-1303-02-S).
Clinical Applications
- Use as the specified interface-cable subassembly in the SmartAblate system.
- Connection within the SmartAblate system according to the system labeling and manufacturer instructions.
- Replacement or supply of the specified cable subassembly when authorized by the applicable SmartAblate system documentation.
Practical Considerations
- This is a system component, not an independently indicated ablation catheter, generator, or treatment device.
- Use only with the compatible SmartAblate system and the specified D-1303-02-S configuration; confirm connector compatibility before use.
- Inspect the cable, connectors, insulation, and strain relief before use. Do not use a cable that is damaged, contaminated, or does not connect securely.
- Follow Biosense Webster and SmartAblate system instructions for installation, cleaning, storage, testing, and replacement.
- MRI safety, cable length, electrical ratings, sterilization requirements, and service life should be confirmed in the current manufacturer labeling. Do not assume the cable is MRI safe.
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.