The information provided here is not intended to provide information to patients and the general public. Coils, stents, filters and vascular grafts have been evaluated relative to the use of MR systems. "The FDA approval of the timing on MRI exams is a significant development for interventional cardiologists and their patients," said Paul LaViolette, Boston Scientific Chief Operating Officer. Language Assistance Available: Espaol | | Ting Vit | | Tagalog | | | Kreyl Ayisyen | Franais | Polski | Portugus | Italiano | Deutsch | | | English, Stents, Drains And Dilators For The Biliary Ducts, Code of Federal Regulations (CFR) Title 21 7.55. From the FastPath Summary screen, select the Print button to print the Diagnostics and any other relevant reports. Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program using an online form, regular mail, or FAX. This press release contains forward-looking statements. Shellock R & D Services, Inc. email: Frank.ShellockREMOVE@MRIsafety.com. Epic Vascular Self-Expanding Stent System - Boston Scientific }7MWJ!%c. An official website of the United States government, : With our stent systems, MRI analyses can now be performed immediately.". No use of any Abbott trademark, trade name, or trade dress in this site may be made without the prior written authorization of Abbott, except to identify the product or services of the company. "The Epic Stent has been very well-received by physicians across the country. GMDN Preferred Term Name GMDN Definition; Polymeric ureteral stent A sterile non-bioabsorbable tubular device intended to be implanted in an obstructed ureter (e.g., from stone, stricture, compression, fibrosis, trauma) to maintain luminal patency allowing urine to drain from the renal pelvis to the bladder. The Sentinol Nitinol Stent System is comprised of two components: the implantable . Boston Scientific Corporation One Boston Scientific Place Natick, MA 01760-1537 1.888.272.1001 www.BostonScientific.com . PDF 2 7 2 Epic Vascular 2 - Boston Scientific Before sharing sensitive information, make sure you're on a federal government site. Fortunately, the devices that exhibited po, 2D Helical, 35 Fibered Platinum Coil. The Express Coronary Stent System was granted approval by Boston Scientific's notified body (TUV Rheinland) to permit CE marking June 18, 2001. Download the MRI Ready Systems Manual or MRI Ready Leadless System Manual to check the MRI scan parameter tables for the applicable scan and identify the settings for RF Transmit Conditions and scan regions. Metal Expandable Biliary Stents - Food and Drug Administration Instructions for Downloading Viewers and Players, Class 3 Device Recall Sentinol Nitinol Biliary Stent System.
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