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Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. There were no stent migrations associated with CEC-adjudicated events at the 30-day primary safety endpoint or through 36 months. An anteroposterior and lateral x-ray for each evaluated stent were sent to an independent core lab for analysis. Directions for Use. Brand Name: Polaris Ultra Commercial Distribution Status: In Commercial Distribution Company Name: BOSTON SCIENTIFIC CORPORATION Primary DI Number: 08714729754565 Issuing Agency: GS1 Commercial Distribution End Date: NA Device Count: 1 Device Description: Ureteral Stent Polaris Ultra - Device Characteristics Polaris Ultra - GMDN Once the test has been completed people can return home and resume normal activities. Three-Year Results from the Venovo Venous Stent Study for the Treatment of Iliac and Femoral Vein Obstruction. Cardiovasc Intervent Radiol, vol. arrhythmia, including ventricular fibrillation, coronary vessel dissection, perforation, rupture or injury, possibly requiring surgical repair or intervention, drug reactions, including allergic reaction to contrast medium, total occlusion of the coronary artery or bypass graft, vessel trauma requiring surgical repair or intervention, See all healthcare professional information, Bladder leakage and pelvic organ prolapse, Enteral feeding tube and esophageal stent device support, Cardiac Resynchronization Therapy (CRT) device support, Peripheral Artery and Vein interventions device support, Transcatheter Aortic Valve Replacement device support, Spinal Cord Stimulator (SCS) systems device support, EDUCARE Medical Education and Training Courses, Patients and Caregivers - Support and Resources, Do not sell or share my personal information. PMA Applicant: Boston Scientific Corporation Address: One Scimed Place, Maple Grove, MN 55311-1566 Approval Date: August 11, 2020 Approval Letter: Approval Order What is it? Coils, Filters, Stents, and Grafts More. Consideration should be taken when this device is used with different manufacturers stents due to differences in stent design.