It was launched in the United States in May of 2012. 2022 Boston Scientific Corporation or its affiliates. 2*Uax?t} 1.5,3: Conditional 5 More . 0.3. Following is some high-level information about preparing for and administering an MRI with patients with a leadless pacemaker, traditional pacemaker, ICD, CRT-D or CRT-P. Once you have completed the checklist, select the Program MRI Settings button to enable MRI Settings. Data from the first human use NG PROMUS Clinical Trial evaluating the safety and effectiveness of the Promus PREMIER Everolimus-Eluting . 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. 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/. One lot of one catalog number of the Sentinol Nitinol Biliary Stent System may have been packaged in a Sentinol nitinol Vascular outer carton. Disposable devices associated with implantation may be included. If our underlying assumptions turn out to be incorrect, or if certain risks or uncertainties materialize, actual results could vary materially from the expectations and projections expressed or implied by our forward-looking statements. 1.5 . Within US to KY, MA, NC, NH, NJ, PA, TX, VA, WA. of Abbott Medical Japan GK. The Epic Nitinol Stent System received CE Mark approval and was launched in Europe and other international markets in 2009. This site is Exclusively Sponsored by BRACCO. MRI safety testing has shown that the REBEL Stent is MR Conditional and that Cautionary Statement Regarding Forward-Looking Statements. You can search by model number or product category. 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? Download the MRI Ready Systems Manual or MRI Ready Leadless System Manual for additional details about patient monitoring. Newmatic Medical, www.newmaticmedical.com. Several of these demonstrated magnetic field interactions. The FDA has identified this as a Class I recall, the most serious type of recall. The Express Coronary Stent System was granted approval by Boston Scientific's notified body (TUV Rheinland) to permit CE marking June 18, 2001. 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. It is made of metal [e.g., stainless steel, nickel-titanium alloy (Nitinol)] and may be inserted with a balloon catheter which causes . Coils, Filters, Stents, and Grafts More. There have been 17 complaints and reported injuries related to this issue. 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. The delivery system is compatible with 0.035 in. Magnetic Resonance MR Conditional 3.0 tesla temperature information Introduction II. 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 [?] Platinum Chromium Coronary Stent System (Monorail) Device Procode: Applicant's Name and Address: NIQ . Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. Note: Boston Scientific is not responsible for the correct use of codes on submitted claims; this informationdoes not constitute reimbursement or legal advice. 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: Patients receiving coronary stents have typically been required to wait approximately two months before receiving an MRI. A migrated stent may require another surgery or catheter procedure to retrieve it, which increases risks to the patient, including possible damage to the blood vessel, heart walls or other organs. %PDF-1.5 % 3: Conditional 6 . 7th.Ine!Y+mOTqDm/`*XBagB8GzXov8P1zluIz y "0!rab/dMwLtX1@_18TUWW\ T/~dc/mRE Instructions for Downloading Viewers and Players. All other trademarks are the property of their respective owners. Unless otherwise specified, all product and service names appearing in this Internet site are trademarks owned by or licensed to Abbott, its subsidiaries or affiliates. Marlborough, MA 01752-1566 . From the FastPath Summary screen, select the Print button to print the Diagnostics and any other relevant reports. 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).? Sterile. 510(K)s with Product Code = FGE and Original Applicant = BOSTON SCIENTIFIC CORP. Download the MRI Ready Systems Manual or MRI Ready Leadless System Manual to review a list of adverse conditions and effects. Sterile. 2023 Boston Scientific Corporation or its affiliates. These forward-looking statements include, among other things, statements regarding our business plans, clinical trials and outcomes, our technology, product performance and importance, and competitive offerings. Epic Stent Boston Scientific, www.bostonscientific.com. You can search by product, model number, category or family. %%EOF Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. 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. Advances in magnetic resonance (MR) imaging and MR angiography over the last 2 decades have led to MR becoming an increasingly attractive imaging modality. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. The .gov means its official.Federal government websites often end in .gov or .mil. %PDF-1.4 % Device Size Text, specify: 75 cm Effective Length, Device Size Text, specify: 40 mm Stent Length, Device Size Text, specify: 10 mm Stent Diameter. Abbotts MRI-Ready High Voltage Device Setup for Gallant and Entrant ICD and CRT-Ds (11:45). This stent has not been evaluated to determine if it is MR Conditional beyond these conditions. Boston Scientific Sentinol Self-Expanding Nitinol Biliary Stent System with Over-the-Wire Delivery System. Our manuals contain the latest instructions and information for cardiac physicians, radiologists and MR technologists. 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 a device is not shown in the list, it is not MR Conditional. @Bd!$7@"rAOgx Boston Scientific performed rigorous laboratory testing to demonstrate MRI compatibility. 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. Made in USA 5905 Nathan Lane, Plymouth, MN 55442, USA. The TAXUS Express2 and Express2 systems were shown to be MRI safe at a high level of magnetic field strengths with minimal effect on temperature rise and drug release. A Boston Scientific Study of the Epic Self-Expanding Nitonol Stent System in the treatment of Atherosclerotic Lesions in Iliac Arteries 0 amputations at 3 years (106 subjects) 89.9% Freedom from TLR at 3 years (143 lesions) ORION US IDE Clinical Trial to demonstrate similar patency across all TASC classifications 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. DVAz~U|OH_P&xuN)Z6:U<0GI+LQj%]mr2&4SCjyWlQq0H[-2vmu5*Q]zp`MocdS.I>^fp~DEBdo(t Boston Scientific, www.bostonscientific.com, Neuroform Atlas Stent Non-clinical testing and analysis have demonstrated that the Neuroform Atlas Stent is MR Conditional alone, or when overlapped with a second stent, and adjacent to a Stryker Neur, AAA Endograft Ovation Ovation Abdominal Stent Graft System TriVascular2, Inc. Santa Rosa, CA, Abre StentMedtronic, Inc., www.Medtronic.com/MRI, Absolute .035 Biliary Self-Expanding StentAbbott Vascular, www.abbottvascular.com, ABSOLUTE 0.35 Biliary Self Expanding Stent System Guidant http://www.guidant.com/ifu/, Absolute Biliary StentAbbott Vascularwww.abbottvascular.com, Absolute Pro .035 Biliary Self-Expanding StentAbbott Vascular, www.abbottvascular.com, Absolute Pro Peripheral Stent Abbott Vascular www.Abbott.com, Absolute Pro Stent Nickel titanium with nickel titanium platinum markers 8-mm x 120-mm Single version Abbott Vascular Santa Clara, CA, Absolute Pro Stent Nickel titanium with nickel titanium platinum markers 8-mm x 348-mm three overlapped version Abbott Vascular Santa Clara, CA, ABSOLUTE Biliary Self-Expanding Stent System Nitinol coils, filters, stents Guidant Endovascular Solutions Santa Clara, CA, Absorb Bioresorbable Vascular Scaffold (BVS) SystemAbbott Vascular, www.abbottvascular.com, Absorb GT1 Bioresorbable Vascular Scaffold (BVS) SystemAbbott Vascular,www.abbottvascular.com, Acculink Carotid StentAbbott Vascularwww.abbottvascular.com, ACCULINK Carotid StentGuidanthttp://www.guidant.com/ifu/, ACS MULTI-LINK Coronary StentAbbott Vascularwww.abbottvascular.com, ACS MULTI-LINK DUET Coronary StentAbbott Vascularwww.abbottvascular.com. MR imaging provides excellent spatial . May be removed prior to MRI and replaced after the MRI exam. The C-code used for this product is C1876, Stent, non-coated/non-covered with delivery system. Before sharing sensitive information, make sure you're on a federal government site. "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. The stent is a laser cut self-expanding stent composed of a nickel titanium alloy(nitinol). These devices are considered MR Unsafe. 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. "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.". No amputations were reported through the 12-month period. 121 0 obj <>stream 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. 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. CAUTION: These products are intended for use by or under the direction of a physician. This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. This includes continuous monitoring of the patient's hemodynamic function. CAUTION: Do not bring any external control devices, such as the Merlin Patient Care System (PCS) Programmer, SJM MRI Activator handheld device, or Aveir Link Module into the scanner magnet room (Zone IV). An official website of the United States government, : Learn the steps for safely preparing Abbotts MRI-Ready GallantTM and EntrantTM High Voltage ICD and CRT-D devices for an MRI scan. Esophageal Stent, Niti-S & Comvi Model E2423 TaeWoong Medical Co., Ltd., www.stent.net. Indicates a trademark of the Abbott group of companies. (,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 C-codesare used for hospital outpatient device reporting for Medicare and some private payers. The stent is constrained within a 6F delivery system. Search for coronary and peripheral disease and valve disease IFUS. Safety Topic / Subject Enterra II Model 37800 Gastric Electrical Stimulation (GES) System . All rights reserved. Be sure to check the lead combination(s) (if applicable) to ensure you select the correct settings. "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 Notice described the issue, identified affected product and asked that the use of affected product be discontinued and affected units be segregated. As a result, readers are cautioned not to place undue reliance on any of our forward-looking statements. Coils, Filters, Stents, and Grafts More. By using this site, you consent to the placement of our cookies. The Epic Stent is compatible with 6F sheaths, and the stent delivery system is compatible with 0.035 inch guidewires. Made in USA 5905 Nathan Lane, Plymouth, MN 55442, USA. Instructions for Downloading Viewers and Players, Class 3 Device Recall Sentinol Nitinol Biliary Stent System. A Recall Notice, dated 05/14/04, was sent to appropriate hospital personnel. Shellock R & D Services, Inc. email: Frank.ShellockREMOVE@MRIsafety.com. Find out who we are, explore careers at the company, and view our financial performance. The ORION clinical data was used to support application for U.S. Food and Drug Administration approval of the Epic Stent System. NOTE: Device diagnostic data may be suspended or cleared when MRI Settings are enabled. This scientific statement is intended to summarize and clarify issues regarding the safety of MR imaging in patients with cardiovascular devices. The information provided here is not intended to provide information to patients and the general public. The Sentinol Nitinol Stent System is comprised of two components: the implantable endoprosthesis and the stent delivery system. "Following the recent presentation of our nine-month data, the 12-month ORION data continue to show very strong clinical outcomes," said Dr. Clair. 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). Dont scan the patient if any adverse conditions are present. 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. Use this database for arrhythmia, heart failure and structural heart products. (0.89mm) guidewires. Our ability to provide a total iliac solution, with the market-leading Express LD Stent and our expansive balloon catheter portfolio, allows Boston Scientific to offer a complete line of advanced solutions to physicians and patients.". 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. 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. Download the MRI Ready Systems Manual or MRI Ready Leadless System Manual to review a list of adverse conditions and effects. These devices are considered MR Unsafe. For more information, please visit: www.bostonscientific.com. f@ The delivery system is of coaxial design with an exterior shaft to protect and constrain the stent prior to deployment. CAUTION: Do not bring any external control devices, such as the Merlin Patient Care System (PCS) Programmer, SJM MRI Activator handheld device, or Aveir Link Module into the scanner magnet room (Zone IV). [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. MRI at 3T or 1.5T may be performed immediately following the implantation of the Epic Stent. 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. Overview of the ELUVIA Drug- Eluting Stent (DES) III. All of these factors are difficult or impossible to predict accurately and many of them are beyond our control. Patients experienced significant clinical improvement from baseline to twelve months based on feedback from validated questionnaires evaluating walking distance, speed and stair climbing. 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. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. Read our privacy policy to learn more. Fortunately, the devices that exhibited po, 2D Helical, 35 Fibered Platinum Coil. Medical Device Recalls, Recalls, Market Withdrawals and Safety Alerts, Boston Scientific Corporation Recalls VICI VENOUS STENT System and VICI RDS VENOUS STENT System for Potential of Stent Migration, VICI VENOUS STENT System (VICI SDS) and VICI RDS VENOUS STENT System, Distribution Dates: September 21, 2018 to April 9, 2021, Health care providers using the VICI VENOUS STENT System and VICI RDS VENOUS STENT System, Patients who have a procedure using the VICI VENOUS STENT System or VICI RDS VENOUS STENT System, Immediately discontinue use of the device, Remove all affected units from inventory and secure them, Complete the company's Verification Form to acknowledge receipt and report products that will be returned, Package affected products for shipping and contact the local Boston Scientific representative to arrange for their return. endstream endobj startxref This press release contains forward-looking statements. Catalog No. Safety Topic / Subject ALIMAXX-B Uncovered Biliary Stent 10-mm x 80-mm . "The Epic Stent is a novel stent platform designed to offer both acute and clinical advantages over older-generation stent systems. The site is secure. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. Results were presented today by Daniel Clair, M.D., FACS, principal investigator of the ORION trial and chairman of the Department of Vascular Surgery at The Cleveland Clinic Foundation, at the 24th Annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium, sponsored by the Cardiovascular Research Foundation. Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. 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. Boston Scientific Sentinol Self-Expanding Nitinol Biliary Stent System with Over-the-Wire Delivery System. The revised Express2 bare-metal stent DFU will be available shortly. As the stent is exposed to body temperature it expands to appose the duct wall. 59 0 obj <> endobj 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. 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. 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. Boston Scientific, www.bostonscientific.com . No deaths have been reported. Interrogate the device with the Merlin PCS Programmer and Aveir Link Module. A tracking/verification form is asked to be returned to Boston Scientific and arrangements will be made for retuning the affected product. [N-'u,uDQOUyUInFl yO/'wjGs1lx"O88KT9/vjTn ]Y~k\}C ? IFbj.)D^7TE.V\Bz->/. 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. Drummond wire (316L SS) orthopedic implant. This site uses cookies. Illustrations are artist's representations only and should not be considered as engineering drawings or photographs. It is required to program the device to MRI Settings as part of the MRI scan workflow. The positive data support the Boston Scientific goal of delivering products designed to reduce the need for reinterventions and help lower overall healthcare costs. If needed, perform capture and sense and lead impedance tests. Use of these devices may cause serious injuries or death. The Express 2 Monorail and Over-the-Wire Coronary Stent Systems have not yet been marketed in any country. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 38948-8607. Reproduced with Permission from the GMDN Agency. Several of these demonstrated magnetic field interactions. 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. Download the MRI Ready Systems Manual or MRI Ready Leadless System Manual for details about checking the MRI Settings status with and without the MRI Activator handheld device. Dry Pad 9 x 9 with Silver Antimicrobial Agent. "The Epic Stent has been very well-received by physicians across the country. 38948-8607. The MRI parameter settings are selected at the physician's discretion. The following pages are intended for medical professionals and provide information on the proper use of products (medical devices, etc.) Please be sure to read it. Boston Scientific Corporation One Boston Scientific Place Natick, MA 01760-1537 1.888.272.1001 www.BostonScientific.com . When ready to be implanted, the stent is deployed by retracting the exterior shaft of the delivery system. GMDN Names and Definitions: Copyright GMDN Agency 2015. Furthermore, outcomes for very complex (TASC C/D) lesions were similar to those reported for less complex (TASC A/B) lesions. 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. The product, pouch label and carton label are all correct and the correct DFU is in the package. Follow the checklist instructions within Merlin PCS Programmer. Boston Scientific Corporation . The TAXUS stent system is the first drug-eluting stent to receive approval for immediate post-procedure MRI. Refer to the manuals for CardioMEMS HF System or MR Conditional ICMs for details about MRIs with those devices. The Epic Stent should not migrate in this MRI environment. The default MRI parameter settings are automatically stored in the Abbott MR Conditional device. Use this database for coronary intervention, peripheral intervention and valve repair products. endstream endobj 60 0 obj <>>>/Filter/Standard/Length 128/O(v~aIgInj rM)/P -1340/R 4/StmF/StdCF/StrF/StdCF/U( ey,62_ )/V 4>> endobj 61 0 obj <>>> endobj 62 0 obj <> endobj 63 0 obj <>/ExtGState<>/Font<>/ProcSet[/PDF/Text]/Properties<>/Shading<>/XObject<>>>/Rotate 0/TrimBox[24.0 24.0 619.276 865.89]/Type/Page>> endobj 64 0 obj <>stream We recommend that you download and review the most current version any time a patient with an Abbott product needs an MRI.

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