1 0 obj << /Creator (Venous Wallstent SSED vers 2 - Microsoft Word) /CreationDate (D:20020508130644Z) /Title (P980033) /Author (Author: ODE) /Producer (Acrobat PDFWriter 5.0 for Windows NT) /Subject (Issue: 11-16-2001) /Keywords (Posted: 05-08-2002) /ModDate (D:20020508134926-03'00') >> endobj 2 0 obj [ /PDF /Text ] endobj 3 0 obj << /Pages 60 0 R /Type /Catalog /Metadata 87 0 R >> endobj 4 0 obj << /Type /Page /Parent 5 0 R /Resources << /Font << /F0 6 0 R /F1 8 0 R /F2 10 0 R /F3 12 0 R >> /ProcSet 2 0 R >> /Contents 14 0 R /Thumb 65 0 R >> endobj 5 0 obj << /Kids [ 4 0 R 16 0 R 21 0 R 27 0 R 30 0 R 36 0 R ] /Count 6 /Type /Pages /Parent 60 0 R >> endobj 6 0 obj << /Type /Font /Subtype /TrueType /Name /F0 /BaseFont /TimesNewRoman /FirstChar 32 /LastChar 255 /Widths [ 250 333 408 500 500 833 778 180 333 333 500 564 250 333 250 278 500 500 500 500 500 500 500 500 500 500 278 278 564 564 564 444 921 722 667 667 722 611 556 722 722 333 389 722 611 889 722 722 556 722 667 556 611 722 722 944 722 722 611 333 278 333 469 500 333 444 500 444 500 444 333 500 500 278 278 500 278 778 500 500 500 500 333 389 278 500 500 722 500 500 444 480 200 480 541 778 500 778 333 500 444 1000 500 500 333 1000 556 333 889 778 611 778 778 333 333 444 444 350 500 1000 333 980 389 333 722 778 444 722 250 333 500 500 500 500 200 500 333 760 276 500 564 333 760 500 400 549 300 300 333 576 453 250 333 300 310 500 750 750 750 444 722 722 722 722 722 722 889 667 611 611 611 611 333 333 333 333 722 722 722 722 722 722 722 564 722 722 722 722 722 722 556 500 444 444 444 444 444 444 667 444 444 444 444 444 278 278 278 278 500 500 500 500 500 500 500 549 500 500 500 500 500 500 500 500 ] /Encoding /WinAnsiEncoding /FontDescriptor 7 0 R >> endobj 7 0 obj << /Type /FontDescriptor /FontName /TimesNewRoman /Flags 34 /FontBBox [ -250 -216 1166 1000 ] /MissingWidth 324 /StemV 73 /StemH 73 /ItalicAngle 0 /CapHeight 891 /XHeight 446 /Ascent 891 /Descent -216 /Leading 149 /MaxWidth 972 /AvgWidth 401 >> endobj 8 0 obj << /Type /Font /Subtype /TrueType /Name /F1 /BaseFont /TimesNewRoman,Bold /FirstChar 32 /LastChar 255 /Widths [ 250 333 555 500 500 1000 833 278 333 333 500 570 250 333 250 278 500 500 500 500 500 500 500 500 500 500 333 333 570 570 570 500 930 722 667 722 722 667 611 778 778 389 500 778 667 944 722 778 611 778 722 556 667 722 722 1000 722 722 667 333 278 333 581 500 333 500 556 444 556 444 333 500 556 278 333 556 278 833 556 500 556 556 444 389 333 556 500 722 500 500 444 394 220 394 520 778 500 778 333 500 500 1000 500 500 333 1000 556 333 1000 778 667 778 778 333 333 500 500 350 500 1000 333 1000 389 333 722 778 444 722 250 333 500 500 500 500 220 500 333 747 300 500 570 333 747 500 400 549 300 300 333 576 540 250 333 300 330 500 750 750 750 500 722 722 722 722 722 722 1000 722 667 667 667 667 389 389 389 389 722 722 778 778 778 778 778 570 778 722 722 722 722 722 611 556 500 500 500 500 500 500 722 444 444 444 444 444 278 278 278 278 500 556 500 500 500 500 500 549 500 556 556 556 556 500 556 500 ] /Encoding /WinAnsiEncoding /FontDescriptor 9 0 R >> endobj 9 0 obj << /Type /FontDescriptor /FontName /TimesNewRoman,Bold /Flags 16418 /FontBBox [ -250 -216 1172 1000 ] /MissingWidth 325 /StemV 136 /StemH 136 /ItalicAngle 0 /CapHeight 891 /XHeight 446 /Ascent 891 /Descent -216 /Leading 149 /MaxWidth 977 /AvgWidth 427 >> endobj 10 0 obj << /Type /Font /Subtype /TrueType /Name /F2 /BaseFont /ArialBlack /FirstChar 32 /LastChar 255 /Widths [ 333 333 500 660 667 1000 889 278 389 389 556 660 333 333 333 278 667 667 667 667 667 667 667 667 667 667 333 333 660 660 660 611 740 778 778 778 778 722 667 833 833 389 667 833 667 944 833 833 722 833 778 722 722 833 778 1000 778 778 722 389 278 389 660 500 333 667 667 667 667 667 389 667 667 333 333 667 333 1000 667 667 667 667 444 611 444 667 611 944 667 611 556 389 278 389 660 750 667 750 278 667 500 1000 667 667 333 1000 722 333 1000 750 722 750 750 278 278 500 500 500 500 1000 333 950 611 333 1000 750 556 778 333 333 667 667 660 667 278 667 333 800 400 667 660 333 800 500 400 660 400 400 333 667 850 333 333 400 400 667 1000 1000 1000 611 778 778 778 778 778 778 1000 778 722 722 722 722 389 389 389 389 778 833 833 833 833 833 833 660 833 833 833 833 833 778 722 667 667 667 667 667 667 667 1000 667 667 667 667 667 333 333 333 333 667 667 667 667 667 667 667 660 667 667 667 667 667 611 667 611 ] /Encoding /WinAnsiEncoding /FontDescriptor 11 0 R >> endobj 11 0 obj << /Type /FontDescriptor /FontName /ArialBlack /Flags 32 /FontBBox [ -250 -310 1200 1101 ] /MissingWidth 389 /StemV 100 /StemH 100 /ItalicAngle 0 /CapHeight 1101 /XHeight 551 /Ascent 1101 /Descent -310 /Leading 410 /MaxWidth 1000 /AvgWidth 552 >> endobj 12 0 obj << /Type /Font /Subtype /TrueType /Name /F3 /BaseFont /Symbol /FirstChar 30 /LastChar 255 /Widths [ 600 600 250 333 713 500 549 833 778 439 333 333 500 549 250 549 250 278 500 500 500 500 500 500 500 500 500 500 278 278 549 549 549 444 549 722 667 722 612 611 763 603 722 333 631 722 686 889 722 722 768 741 556 592 611 690 439 768 645 795 611 333 863 333 658 500 500 631 549 549 494 439 521 411 603 329 603 549 549 576 521 549 549 521 549 603 439 576 713 686 493 686 494 480 200 480 549 600 600 600 600 600 600 600 600 600 600 600 600 600 600 600 600 600 600 600 600 600 600 600 600 600 600 600 600 600 600 600 600 600 600 620 247 549 167 713 500 753 753 753 753 1042 987 603 987 603 400 549 411 549 549 713 494 460 549 549 549 549 1000 603 1000 658 823 686 795 987 768 768 823 768 768 713 713 713 713 713 713 713 768 713 790 790 890 823 549 250 713 603 603 1042 987 603 987 603 494 329 790 790 786 713 384 384 384 384 384 384 494 494 494 494 600 329 274 686 686 686 384 384 384 384 384 384 494 494 494 600 ] /FontDescriptor 13 0 R >> endobj 13 0 obj << /Type /FontDescriptor /FontName /Symbol /Flags 6 /FontBBox [ -250 -220 1252 1005 ] /MissingWidth 333 /StemV 109 /StemH 109 /ItalicAngle 0 /CapHeight 1005 /XHeight 503 /Ascent 1005 /Descent -220 /Leading 225 /MaxWidth 1043 /AvgWidth 600 >> endobj 14 0 obj << /Length 15 0 R /Filter /FlateDecode >> stream A stent delivery system for a balloon expandable stent consists All rights reserved. BSC began marketing the product internationally following approval in September 2001. "Patients undergoing stent procedures can now avoid the long waiting period previously required before receiving MRI diagnostics during the most critical stage of their recovery. The .gov means its official.Federal government websites often end in .gov or .mil. epic vascular self-expanding stent system: Boston Scientific Corp. P110035 S045: 04/03/2018: memorygel silicone gel-filled breast implants: MENTOR CORP. P030053 S045: 01/30/2018: reflection ceramic acetabular hip system: Smith & Nephew, Inc. P030022 S045: Be sure to check the lead combination(s) (if applicable) to ensure you select the correct settings. These forward-looking statements are based on our beliefs, assumptions and estimates using information available to us at the time and are not intended to be guarantees of future events or performance. The prospective, single-arm ORION trial enrolled 125 patients at 28 sites in the United States. These factors, in some cases, have affected and in the future (together with other factors) could affect our ability to implement our business strategy and may cause actual results to differ materially from those contemplated by the statements expressed in this press release. Paul, M, Esophageal Reconstruction TubeHood Laboratories, www.hoodlabs.com, Esophageal Stent, Niti-S & Comvi Model E2423TaeWoong Medical Co., Ltd., www.stent.net, Esophageal StentHood Laboratories, www.hoodlabs.com, Esophageal TTS StentTaeWoong Medical Co., Ltd., www.stent.net, Esophagus Full-Covered StentCG BIO CO., LTD. www.cgbio.co.kr/en/. Physicians interested in reviewing a complete copy of the revised TAXUS Express2 stent DFU may obtain a copy from the TAXUS website at www.taxus-stent.com. 300 Boston Scientific Way . The stent is constrained within a 6F delivery system. This scientific statement is intended to summarize and clarify issues regarding the safety of MR imaging in patients with cardiovascular devices. Boston Scientific performed rigorous laboratory testing to demonstrate MRI compatibility. For more information, please visit: www.bostonscientific.com. We recommend that you download and review the most current version any time a patient with an Abbott product needs an MRI. 1) Confirm MRI readiness. NATICK, Mass., Oct. 23, 2012 /PRNewswire/ --Boston Scientific Corporation (NYSE: BSX) reports twelve-month clinical endpoint data from the ORION trial, which demonstrated robust safety and effectiveness outcomes for the Epic Self-Expanding Nitinol Stent System in patients with obstructed iliac arteries. The Merlin PCS Programmer will print to the default printer (internal printer, external printer or PDF). Safety Topic / Subject Enterra II Model 37800 Gastric Electrical Stimulation (GES) System . @Bd!$7@"rAOgx 1.5,3: (,OcEh{[%E#Xl@::9(k]xv# q#fs+[Jb{-$r;EB9 pdRkEdq^(PFG3|'ae1wsv4N5:YBswO[kQC9U0EJ[Tkd/*4s3_SN}W~jj,SPuT-9 )44ZtGtWAO@Fo aP3lqS-P*)v"rj5QEWL!zg8KbORyvm?B'tZ&3D#>7"7Q8&a*$"xmVTeV [@[@.o)BpiyHpV1FIh\w|wD!2N^# U#gb a]qkz,'@Ri3 Download the MRI Ready Systems Manual or MRI Ready Leadless System Manual to see examples of checklist screens and get additional details about the checklist. 3: Conditional 6 . Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. A Recall Notice, dated 05/14/04, was sent to appropriate hospital personnel. About Epic and the ORION Trial The Epic Stent is a self-expanding nitinol stent designed to sustain vessel patency, while providing enhanced visibility and accuracy during placement. From the FastPath Summary screen, select the Print button to print the Diagnostics and any other relevant reports. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. Patients receiving coronary stents have typically been required to wait approximately two months before receiving an MRI. Boston Scientific Corporation . Company Name: BOSTON SCIENTIFIC CORPORATION Primary DI Number: 08714729802976 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 [?] MRI safety testing has shown that the REBEL Stent is MR Conditional and that Read our privacy policy to learn more. Results were presented today by Daniel Clair, M.D., FACS, principal investigator of the . Conditional 6 More. MRI at 3T or 1.5T may be performed immediately following the implantation of the Epic Stent. Boston Scientific Sentinol Self-Expanding Nitinol Biliary Stent System with Over-the-Wire Delivery System. The Notice described the issue, identified affected product and asked that the use of affected product be discontinued and affected units be segregated. NATICK, Mass., Oct. 23, 2012 /PRNewswire/ -- Boston Scientific Corporation (NYSE: BSX) reports twelve-month clinical endpoint data from the ORION trial, which demonstrated robust safety and effectiveness outcomes for the Epic Self-Expanding Nitinol Stent System in patients with obstructed iliac arteries. 2022 Boston Scientific Corporation or its affiliates. 2023 Boston Scientific Corporation or its affiliates. Device setup, user manuals and troubleshooting, The Boston Scientific Epic Stent Continues to Demonstrate Positive Clinical Outcomes for Patients with Iliac Artery Disease, Twelve-Month Data Presented at TCT 2012 Support Safety and Efficacy of Epic Stent in Iliac Stenting, Lab Agent - Restock Products For Your Practice, 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, ADVANTICS Innovative Healthcare Solutions, Do not sell or share my personal information. 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. [N-'u,uDQOUyUInFl yO/'wjGs1lx"O88KT9/vjTn ]Y~k\}C ? If you are not using the MRI Activator, MRI Settings must be disabled by the patient's device management physician or clinician using the Merlin PCS Programmer and Aveir Link Module (if applicable). The following pages are intended for medical professionals and provide information on the proper use of products (medical devices, etc.) Coronary data supports safety of paclitaxel and ELUVIA DES IV. The ORION clinical data was used to support application for U.S. Food and Drug Administration approval of the Epic Stent System. Search for arrhythmia, heart failure and structural heart IFUs. Major adverse events are defined as death within 30 days, myocardial infarction (MI, or heart attack) occurring during hospitalization, target vessel revascularization (TVR) through nine months and amputation of the treated limb through nine months. Magnetic Resonance MR Conditional 3.0 tesla temperature information Learn more about solutions for your specialty area, Device setup, user manuals and troubleshooting, 12-month Primary Patency by TASC Classification, See all healthcare professional information, Lab Agent - restock products for your practice, 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, Epic Vascular Self-Expanding Stent System, EDUCARE Medical Education and Training Courses, ADVANTICS Innovative Healthcare Solutions, Do not sell or share my personal information, 0 amputations at 3 years (106 subjects), ORION US IDE Clinical Trial to demonstrate similar patency across all TASC classifications, Tandem Architecture Stent Design features Macro, Medium and Micro Struts, as well as patented connector patternsdesigned to optimize flexibility, Hybrid Architecture Design with open- and closed-cell geometry engineered to provide flexibility and deployment uniformity, Macro and Micro Struts are engineered to work in tandem for balanced forceeven in tortuous vasculature, Ergonomic handle with two convenient deployment options: thumb wheel and pull grip, Radiopaque stent markers and catheter shaft marker band enhance visibility and simplify placement, Meticulous surface finishing and polishing to remove imperfections and improve fracture resistance, Tandem Architecture Stent Design engineered to bend and flex and reduce the risk of fracture, 0% Amputation of index limb at 12-months (0/111). Data from the first human use NG PROMUS Clinical Trial evaluating the safety and effectiveness of the Promus PREMIER Everolimus-Eluting . 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. Introduction II. Abbotts MRI-Ready High Voltage Device Setup for Gallant and Entrant ICD and CRT-Ds (11:45). Instructions for Downloading Viewers and Players. Device Size Text, specify: 75 cm Effective Length, Device Size Text, specify: 40 mm Stent Length, Device Size Text, specify: 10 mm Stent Diameter. As a result, DFUs for stent systems containing metal usually recommend a waiting period of approximately two months from the time of implantation until an MRI can be performed safely. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. Furthermore, outcomes for very complex (TASC C/D) lesions were similar to those reported for less complex (TASC A/B) lesions. The revised Express2 bare-metal stent DFU will be available shortly. Immediately following the MRI procedure, follow the instructions in the MRI Ready Systems Manual or MRI Ready Leadless System Manual to revert to the permanently programmed settings. The product, pouch label and carton label are all correct and the correct DFU is in the package. It was launched in the United States in May of 2012. The FDA has identified this as a Class I recall, the most serious type of recall. Fortunately, the devices that exhibited po, 2D Helical, 35 Fibered Platinum Coil. Illustrations are artist's representations only and should not be considered as engineering drawings or photographs. Upon approval, the Epic Stent along with the market-leading Express LD balloon-expandable iliac stent, would enable Boston Scientific to offer a complete line of advanced iliac solutions for physicians and patients." IFbj.)D^7TE.V\Bz->/. Sterile. Made in USA 5905 Nathan Lane, Plymouth, MN 55442, USA. When ready to be implanted, the stent is deployed by retracting the exterior shaft of the delivery system. A non-bioabsorbable tubular device intended to be implanted in the common and/or external iliac artery (ies) to maintain arterial patency and luminal diameter in patients with symptomatic atherosclerotic disease. A non-bioabsorbable tubular device intended to be implanted in the common and/or external iliac artery(ies) to maintain arterial patency and luminal diameter in patients with symptomatic atherosclerotic disease. If needed, perform capture and sense and lead impedance tests. Due to the use of intense magnetic fields in MRI examinations, implanted medical devices that contain metal may be subject to potential migration and heating within the body. Boston Scientific Corporation Customer Service: 8882721001 www.bostonscientific.com Page 1 of 12 PI86716AG Magnetic Resonance Imaging (MRI) Safety for Boston Scientific Products Table of Contents 1. [prod, crx3, samplecontent, publish, crx3tar], https://vascular.abbott.com/,https://mri.merlin.net/,https://www.thelancet.com/,https://www.ahajournals.org/,https://www.onlinejacc.org/,https://jamanetwork.com/,https://www.sciencedirect.com/,https://onlinelibrary.wiley.com/,https://www.cms.gov/,https://www.novitas-solutions.com/,https://event.on24.com/,https://dx.doi.org/,https://www.myloopaccount.com/,https://www.invasivecardiology.com/,https://manuals.sjm.com/,https://www.cardiovascular.abbott, MRI Ready Systems Manual or MRI Ready Leadless System Manual, Interrogate the device with the Merlin PCS Programmer. Follow the checklist instructions within Merlin PCS Programmer. Applicant's Name and Address: Boston Scientific Scimed Inc. One Scimed Place Maple Grove MN 55311-1566 PMA Number: P980033 Date of Notice of Approval to the Applicant: Novermber 16, 2001 2. A tracking/verification form is asked to be returned to Boston Scientific and arrangements will be made for retuning the affected product. Instructions for Downloading Viewers and Players, Class 3 Device Recall Sentinol Nitinol Biliary Stent System. Boston Scientific is recalling the VICI SDS and RDS VENOUS STENT Systems after reports indicate that the stents may migrate or move from where they are initially implanted. Boston Scientific wishes to caution the reader of this press release that actual results may differ from those discussed in the forward-looking statements and may be adversely affected by, among other things, risks associated with new product development and commercialization, clinical trials, intellectual property, regulatory approvals, competitive offerings, integration of acquired companies, Boston Scientific's overall business strategy, and other factors described in Boston Scientific's filings with the Securities and Exchange Commission. The delivery system is of coaxial design with an exterior shaft to protect and constrain the stent prior to deployment. Refer to the manuals for CardioMEMS HF System or MR Conditional ICMs for details about MRIs with those devices. It employs an innovative Tandem Architecture, which is engineered to provide excellent stent flexibility while maintaining predictable radial force characteristics across a variety of stent sizes. Esophageal Stent, Niti-S & Comvi Model E2423 TaeWoong Medical Co., Ltd., www.stent.net. 2022 Boston Scientific Corporation or its affiliates. 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. Refer to the . On April 12, 2021, Boston Scientific Corporation sent an Urgent Medical Device Recall Notification to customers asking them to: Customers with questions should contact their Boston Scientific sales representative. Marlborough, MA 01752-1566 . Forward-looking statements may be identified by words like "anticipate," "expect," "project," "believe," "plan," "estimate," "intend" and similar words. Alternatively, you can also use the latest MRI Manuals to determine scan parameters. PARIS, May 22, 2013 /PRNewswire/ -- Boston Scientific Corporation (NYSE: BSX) reports positive results from two trials evaluating new, innovative drug-eluting stent (DES) technologies, which are emerging treatment options for coronary heart disease. With our stent systems, MRI analyses can now be performed immediately.". Device setup, user manuals and troubleshooting, (April 5, 2005) -- Boston Scientific Corporation (NYSE: BSX) today announced that the U.S. Food and Drug Administration (FDA) has approved enhancements to the Directions for Use (DFU) of the TAXUS Express, Lab Agent - Restock Products For Your Practice, 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, ADVANTICS Innovative Healthcare Solutions, Do not sell or share my personal information. 59 0 obj <> endobj CAUTION: These products are intended for use by or under the direction of a physician. Magnetic Resonance Imaging (MRI) Safety for Boston Scientific Peripheral Products PDF, 272.0 KB. The VICI SDS and VICI RDS VENOUS STENT Systems are intended for the treatment of obstructions and occlusions in the narrowed or blocked venous veins. Please be sure to read it. The MRI parameter settings are selected at the physician's discretion. 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. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. No deaths have been reported. Sterile. Indicates a third party trademark, which is property of its respective owner. Safety Info ID# Safety Topic / Subject Article Text 171: Coils, Filters, Stents, and Grafts: Coils, stents, filters and vascular grafts have been evaluated relative to the use of MR systems. This press release contains forward-looking statements. Coils, stents, filters and vascular grafts have been evaluated relative to the use of MR systems. We disclaim any intention or obligation to publicly update or revise any forward-looking statements to reflect any change in our expectations or in events, conditions or circumstances on which those expectations may be based, or that may affect the likelihood that actual results will differ from those contained in the forward-looking statements. Stent delivery system (SDS): A system that delivers a biliary stent to a target site within the bile duct and then deploys the stent. Find products, medical specialty information, and education opportunities. HWnFC=ji6n 9/~\:\$$rxnsU,)Ielo((a,$4bY?W7)MoQEHk1s-;]zXJ$G=0.F4VJYwS|U9VOU@n0ZL26w~+y38.$qW|%-zu'2g:,IwA28nvnP R%ivTpks5>/m5p)H,!HIsqz 9x?pFH=@q}+[|Gd $Xp7lXcV5ZID?vM1V]kM).? Company Name: BOSTON SCIENTIFIC CORPORATION Primary DI Number: 08714729959915 Issuing Agency: GS1 Commercial Distribution End Date: Device Count: 1 Labeler D-U-N-S Number*: 021717889 * Terms of Use Device Description: Ureteral Stent With Side Holes 6Fx28CM CLOSE Device Characteristics Device Record Status Alternative and Additional Identifiers Use of these devices may cause serious injuries or death. These devices are considered MR Unsafe. Shellock R & D Services, Inc. email: Frank.ShellockREMOVE@MRIsafety.com. of Abbott Medical Japan GK. This cautionary statement is applicable to all forward-looking statements contained in this document. GMDN Names and Definitions: Copyright GMDN Agency 2015. This includes continuous monitoring of the patient's hemodynamic function. %PDF-1.5 % Boston Scientific Sentinol Self-Expanding Nitinol Biliary Stent System with Over-the-Wire Delivery System. Platinum Chromium Coronary Stent System (Monorail) Device Procode: Applicant's Name and Address: NIQ . You can search by product, model number, category or family. Coils, Filters, Stents, and Grafts More. Made in USA 5905 Nathan Lane, Plymouth, MN 55442, USA. Epic is a registered or unregistered trademark of Boston Scientific Corporation or its affiliates. The trial previously met its primary endpoint of major adverse events (MAE) at nine months with a rate of 3.4 percent for the Epic Stent compared to a pre-specified performance goal. Search for coronary and peripheral disease and valve disease IFUS. The Boston Scientific ELUVIA Drug-Eluting Vascular Stent System is a medical device containing an ancillary medicinal substance, which provides a mechanical scaffold for vascular lumen support (the stent component) and a pharmacological agent (paclitaxel) targeted towards reducing the injury response that leads to restenosis after Interrogate the device with the Merlin PCS Programmer and Aveir Link Module. Safety Topic / Subject ALIMAXX-B Uncovered Biliary Stent 10-mm x 80-mm . "The performance of the Epic Stent in challenging iliac artery lesions and the long-term demonstration of both safety and efficacy of the Epic Stent is another example of our ability to offer patients a durable treatment option for iliac artery disease.". As a result, readers are cautioned not to place undue reliance on any of our forward-looking statements. For more information, please visit: www.bostonscientific.com. 0.3. 2*Uax?t} An official website of the United States government, : Epic Stent Boston Scientific, www.bostonscientific.com. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. Date of Panel Recommendation: None Premarket Approval Application (PMA) Number: P150003/S058 Date of FDA Notice of Approval: August 10, 2020 Many of our pacemakers (leadless and traditional), ICDs, ICMs, CRT-Ds, CRT-Ps, pressure sensors, heart valves, occluders and annuloplasty rings are MR Conditional. Download the MRI Ready Systems Manual or MRI Ready Leadless System Manual to review how data will be handled by each system. 38948-8607. Learn the steps for safely preparing Abbotts MRI-Ready GallantTM and EntrantTM High Voltage ICD and CRT-D devices for an MRI scan. About Boston ScientificBoston Scientific is a worldwide developer, manufacturer and marketer of medical devices that are used in a broad range of interventional medical specialties.
Industrial Units To Let Heckmondwike, Articles B