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.
“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.
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.
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 #) 83726, || Description: 1304-7-25-XL-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.