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As a result, we might acquire some images from a patient who does not haveanMRI-conditionaldevice that we wont on a patient who has one.. Indicates that the product is comprised of two or more regulated products that are physically, chemically, or otherwise combined or mixed and produced as a single entity; packaged together as a single package; or packaged separately for the intended use together as defined under 21 CFR 3.2(e). The site is secure. : Boston Scientific Corp. N970003 S283: 04/21/2023: cognis, energen, punctua, incepta, origen, inogen,. If you are interested in learning more about ICD and S-ICD devices, please visit the ICDs and S-ICDs procedure page for more information. Advertising on our site helps support our mission. Everything you need to know about living with a subcutaneous or transvenous defibrillator device. A battery-powered, hermetically-sealed pulse generator with a cardiac rhythm recognition system intended to collect and analyse electrocardiogram (ECG) data and deliver appropriate electrical impulses to defibrillate the heart (restore normal rhythm) or slow a rapid heart rate, and to pace the heart (to treat bradycardia). The Donation Identification Number is applicable to devices that are also regulated as HCT/Ps and is a number that is assigned to each donation. All rights reserved. Labeling does not contain MRI Safety Information. Brand Name: ENERGEN ICD Version or Model: E143 Commercial Distribution Status: In Commercial Distribution Catalog Number: Company Name: BOSTON SCIENTIFIC CORPORATION Primary DI Number: 00802526480744 Issuing Agency: GS1 Commercial Distribution End Date: Device Count: 1 Labeler D-U-N-S Number*: 106295384 * Terms of Use Once the wires are in place, they are attached to the heart wall. ACUITYTM X4: 4671, 4672, 4674, 4675, 4677, 4678 PDF Urgent Field Safety Notice Dimension type for the clinically relevant measurement of the medical device. Before sharing sensitive information, make sure you're on a federal government site. To obtain a copy of the device Patient Handbook for more detailed device safety information, go to www.bostonscientific.com , or you can request a copy by calling 1-866-484-3268 or writing to Boston Scientific, 4100 Hamline Ave. N., St. Paul, MN 55112. Your permanent Medical Device Identification (ID) Card will be mailed to you a few weeks after your implant. Although the scan will not affect your device, ifitson the larger side, your device can sometimes affect image quality. All rights reserved. Supported by working group of pacing and electrophysiology of the FrenchSocietyofCardiology, I do not have an account: access CREATION, Specific conditions from the manufacturer, Download pdf (S-ICD) (document provided by the manufacturer), Download pdf (PACING) (document provided by the manufacturer), Download pdf (DEFIBRILLATION) (document provided by the manufacturer), Filters changed, please click to submit when done, In combinaison with Boston Scientific compatible MRI leads.