“We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
International distribution only: Canada and Japan.
Descripción del producto
1500T12 Cool Path Ablation System - Generator || The generator is a microprocessor-controlled device that produces a continuous unmodulated radiofrequency (RF) output of 485 kHz. The generator has a maximum power output of 100 Watts. The catheter delivers the RF power from the generator in a monopolar mode between its distal electrode (tip electrode) and a large indifferent electrode (dispersive pad or "DIP"), which is in compliance with ANSUAAMI Standard HF-18-60601-2-2. The Generator operates in Temperature Control mode only. The generator is a temperature controlled system, where temperature measured by the temperature sensor in the Therapy 1300 Series Steerable Ablation Catheter or other compatible catheters is monitored and the power delivered by the generator adjusts within the selected limits until the desired temperature is achieved. The generator's thermocouple temperature control circuitry is based on a Type T thermocouple. The front panel displays the actual real-time power output, impedance, duration, and measured tip electrode temperature. The amount and duration of RF power delivery is user selectable, The desired catheter tip electrode temperature is also user selectable. A low pass filter is enabled during ablation to permit recording of intracardiac electrograms and alternately disables the filter during stimulation (pacing). The output power of the Generator will shut off if the measured temperature exceeds 80¿C or if the measured temperature exceeds the user selected temperature set point by more than 5¿C for more than 3 seconds. The Generator has built-in safety features, which include a self test at power up and automatic RF power shut off if the measured tissue impedance falls below 50 Ohms or exceeds 300 Ohms or the preset impedance value for more than 2 seconds. The 1500Tl2 Cardiac Ablation Generator is only compatible with the Cool Point Irrigation Pump.
International distribution only: Canada and Japan.
Descripción del producto
1500T14 Cardiac Ablation System - Generator || The 1500Tl4 Cardiac Ablation System operates in conjunction with a commercially available external Disposable Indifferent (Dispersive) Patch (DIP) electrode. The catheter delivers RF power in a monopolar mode between its distal electrode and the DIP electrode. The Generator incorporates a medical grade power supply. This power supply can be used for various line voltages and frequencies without any modifications. Utilizing microprocessor control, the Generator produces a continuous nonmodulated radio frequency (RF) output at 485 KHz. Its front panel displays the command power output, tissue impedance, and tissue temperature. The Generator measures root-mean-square (RMS) voltage, RMS current, and command power output by taking the average value of the product of voltage and current. This reflects the effective heating power delivered to the tissue from the catheter large electrode (tip electrode or other ablating electrodes). Impedance is calculated as RMS voltage divided by RMS current. The amount and duration of RF power delivery is user- selectable. The Generator has four (4) independent channels for monitoring the tissue temperature simultaneously using thermocouple sensor and i-channel (thermistor) for catheters using a thermistor sensor. The desired temperature is user-selectable when busing a catheter with a temperature sensor. If using a catheter with a temperature sensor, the output power of the Generator will shut off if the measured temperature exceeds 80¿C or if the measured temperature exceeds the user-selected temperature set point by more than 5¿C for greater than 3 seconds. If using a catheter with 4 temperature sensors, the output power of the Generator will shut off when the highest temperature detected from anyone of the temperature sensors is exceeds the preset temperature by more than 5¿C for greater than 3 seconds or exceeding 80¿C.The Generator has built-in safety features which include automatic RF power shutoff if the measured tissue impedance falls below 50 ohms or exceeds 300 ohms or the preset impedance value.
Serial Number: 13615332, 13615330, 13615328, 13615331
Distribución
International distribution only: Canada and Japan.
Descripción del producto
1500T14 Cardiac Ablation System - Remote Control || The 1500Tl4 Remote Control can control and operate the 1500Tl4 RF generator remotely via a connecting cable. It has a duplicate front panel controls and displays as of the generator's front panel, with the addition of an optical encoder knob which is used to select and changes the parameters.
Nationwide Distribution including the states of TN, MS, IN, MO, FL, WI, CA, and MT.
Descripción del producto
7 F Therapy Ablation Catheter, || 4 mm Tip Thermistor, || Model (Reorder #) 83724, || Description: 1304-7-25-M-TH. || St Jude Medical Company || A sterile, single use catheter with one 4mm ablation electrode at the tip and three 2mm diagnostic electrodes. The catheter includes a temperature sensor in the tip electrode for temperature monitoring and the handle is equipped with a steering mechanism to detect the distal tip of the catheter; both uni-directional and bi-directional versions are available. The catheter is available with various distal curve configurations; the curve is indicated on the catheter label.
Nationwide Distribution including the states of TN, MS, IN, MO, FL, WI, CA, and MT.
Descripción del producto
7 F Therapy Ablation Catheter, || 4 mm Tip Thermistor, || Model (Reorder #) 83725, || Description: 1304-7-25-L-TH. || St Jude Medical Company || A sterile, single use catheter with one 4mm ablation electrode at the tip and three 2mm diagnostic electrodes. The catheter includes a temperature sensor in the tip electrode for temperature monitoring and the handle is equipped with a steering mechanism to detect the distal tip of the catheter; both uni-directional and bi-directional versions are available. The catheter is available with various distal curve configurations; the curve is indicated on the catheter label.
“We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
“We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
“We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
“We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
“We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.