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Therapy Cool Path Ablation Catheter & IBI 1500T9

FDA PMA

Class III (US FDA PMA)

PMA P060019

by Irvine Biomedical, Inc.

Identity

Trade Name
IBI THERAPY COOL PATH ABLATION CATHETER & IBI-1500T9 RF FDA PMA
Generic Name
catheter, percutaneous, cardiac ablation, for treatment of atrial flutter FDA PMA

Identifiers

PMA Number
P060019 FDA PMA
FDA Product Code
OAD FDA PMA

Classification

Device Class
Class III FDA PMA
Advisory Committee
Cardiovascular FDA PMA
FDA Decision
APPR Approved FDA PMA

The Therapy Cool Path Ablation Catheter & IBI 1500T9 is a percutaneous cardiac ablation catheter system intended for use with a compatible external infusion pump and the IBI 1500T9 radiofrequency (RF) generator at a maximum of 50 watts. It is designed for creating endocardial lesions during cardiac ablation procedures (mapping, stimulation and ablation) for the treatment of typical atrial flutter.

The system requires a compatible external infusion pump when used with the Therapy Cool Path catheter. The IBI 1500T9 RF ablation generator is internally limited to 50 watts when used with these catheters and is intended for use with compatible St. Jude Medical temperature-controlled ablation catheters to treat cardiac arrhythmias including supraventricular tachycardias and atrial flutter. The device is supplied as a single-use system and has received FDA PMA approval (P060019).

Frequently asked questions

What is the maximum power setting for the IBI 1500T9 generator when used with the Therapy Cool Path catheter?

The IBI 1500T9 RF ablation generator is internally limited to 50 watts when used with the Therapy Cool Path catheters, as specified in the approval documentation.

Is an external infusion pump required when using the Therapy Cool Path catheter with the IBI 1500T9 generator?

Yes, a compatible external infusion pump must be connected when using the Therapy Cool Path catheter with the IBI 1500T9 RF ablation generator, as stated in the device's approval conditions.

What cardiac condition is the Therapy Cool Path Ablation Catheter & IBI 1500T9 system intended to treat?

The system is intended for the treatment of typical atrial flutter by creating endocardial lesions during cardiac ablation procedures that include mapping, stimulation, and ablation.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_PMA

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Manufacturer

Manufacturer
Irvine Biomedical, Inc.

Sources (1)

  • FDA PMA P060019 24 fields · synced Sep 18, 2026