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Proper patient monitoring must be provided during the MRI scan. Made in USA 5905 Nathan Lane, Plymouth, MN 55442, USA. Read our privacy policy to learn more. Download the MRI Ready Systems Manual or MRI Ready Leadless System Manual to review how data will be handled by each system. Are you a healthcare professional? Search for arrhythmia, heart failure and structural heart IFUs. For a further list and description of these and other important risks and uncertainties that may affect our future operations, see Part I, Item 1A Risk Factors in our most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission, which we may update in Part II, Item 1A Risk Factors in Quarterly Reports on Form 10-Q we have filed or will file hereafter. 2022 Boston Scientific Corporation or its affiliates. 0.3. The MAE rate at 12 months was 5.4 percent, with all MAEs related to TVR. The product, pouch label and carton label are all correct and the correct DFU is in the package. The prospective, single-arm ORION trial enrolled 125 patients at 28 sites in the United States. %PDF-1.5 % It is made of metal [e.g., stainless steel, nickel-titanium alloy (Nitinol)] and may be inserted with a balloon catheter which causes the device to expand when inflated, or it may self-expand after insertion with a delivery device. THE List - MRI Safety The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. MR imaging provides excellent spatial . Safety Topic / Subject Enterra II Model 37800 Gastric Electrical Stimulation (GES) System . Note: If you need help accessing information in different file formats, see Coils, Filters, Stents, and Grafts More. Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. AccessGUDID - DEVICE: Tria Soft (08714729959915) Testing, Training, and Books Implant & Device Testing MAGNETIC RESONANCE SAFETY TESTING SERVICES is a highly experienced MRI-safety testing company that conducts comprehensive evaluations of implants, devices, objects, and materials. Ideal for the Iliac: The Epic Stent is a self-expanding Nitinol stent designed to sustain vessel patency, while providing enhanced visibility and accuracy during placement. Company Name: BOSTON SCIENTIFIC CORPORATION Primary DI Number: 08714729861775 Issuing Agency: GS1 Commercial Distribution End Date: Device Count: 1 Labeler D-U-N-S Number*: 021717889 * Terms of Use Device Description: Ureteral Stent CLOSE Device Characteristics Device Record Status Alternative and Additional Identifiers Customer Contact [?] An official website of the United States government, : 7th.Ine!Y+mOTqDm/`*XBagB8GzXov8P1zluIz y "0!rab/dMwLtX1@_18TUWW\ T/~dc/mRE