PLEASE REFER TO THE LABELING FOR A MORE COMPLETE LIST OF WARNINGS, PRECAUTIONS AND CONTRAINDICATIONS. All trademarks are the property of their respective owners. Other health care professionals should select their country in the top right corner of the website. Stent Placement Accuracy Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. <]>> 0 - Boston Scientific Medical device safety alert: boston scientific advanix biliary stent with naviflex rx delivery system medical device manufacturer, boston scientific corporation issued a medical device safety alert concerning advanix biliary stent with naviflex rx delivery system (catalogue number: 3427 . Radiopaque marker on leading end of the Advanix Pancreatic Stent provides visibility under fluoroscopy.*. The NaviFlex RN Delivery System will be offered in 202.5cm working length. Disposable devices intended to assist implantation may be included. The RX biliary delivery system is reconstrainable up to 80% of deployment to aid in repositioning*** and is designed to facilitate physician control. 0000006770 00000 n LIMITATIONS Coils, Filters, Stents, and Grafts More. 0000001584 00000 n A sterile non-bioabsorbable tubular device intended to be implanted in an obstructed biliary duct (e.g., common bile duct) to maintain luminal patency. It is made entirely of a synthetic polymer(s) [e.g., polytetrafluoroethylene (PTFE), polyethylene (PE), silicone] and may have various designs (e.g., continuous tube with or without drainage side holes, covered or non-covered mesh structure). * Compatible with Boston Scientific .035" guidewires, including Dreamwire Guidewire. The WallFlex Biliary RX Fully Covered Stent should not be placed in strictures that cannot be dilated enough to pass the delivery system, in a perforated duct, or in very small intrahepatic ducts. Endoscopically-placed stents are a clinically effective treatment for biliary Warnings: The safety and effectiveness of the stent has not been established for indwell periods exceeding 12 months. stents, drains and dilators for the biliary ducts: 510(k) Number: K101314: Device Name: ADVANIX BILIARY STENT WITH NAVIFLEX RX DELIVERY SYSTEM: Applicant: BOSTON SCIENTIFIC CORP. 100 BOSTON SCIENTIFIC WAY . 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 0000016595 00000 n 0000002593 00000 n 0000031716 00000 n 0000001521 00000 n Cotton-Leung Biliary Stent only | Cook Medical Cotton-Leung Biliary Stent only Documents Images Used to drain obstructed biliary ducts. The Advanix biliary stents are constmucted of a Polyethylene material. Warning: No warranty is made with regard to removability of this device by endoscopic means or otherwise. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. Coils, Filters, Stents, and Grafts More. 2023 Boston Scientific Corporation or its affiliates. Disposable devices intended to assist implantation may be included. Post date June 29, 2022; Categories In words to describe your personal identity; name a creature that invades your home family feud . The sternt lengths for each diameter vary from 5cm-l 8cm stent lengths. * Compatible with Boston Scientific .035" guidewires, including Dreamwire Guidewire. A sterile non-bioabsorbable tubular device intended to be implanted in an obstructed biliary duct (e.g., common bile duct) to maintain luminal patency. Indications, contraindications, warnings and instructions for use can be found in the product labeling. 0000032536 00000 n Stents are not a magnetic resonance imaging (MRI) contrast medium. 0000003169 00000 n Are you a Medical Device Company? endstream endobj 100 0 obj<> endobj 101 0 obj<>/Shading<>/ColorSpace<>/Font<>/ProcSet[/PDF/Text/ImageC]/ExtGState<>>>/Type/Page>> endobj 102 0 obj<> endobj 103 0 obj[/Separation/PANTONE#203145#20C/DeviceCMYK 131 0 R] endobj 104 0 obj[/Separation/PANTONE#203145#20C/DeviceCMYK 129 0 R] endobj 105 0 obj<> endobj 106 0 obj<> endobj 107 0 obj<> endobj 108 0 obj<> endobj 109 0 obj<> endobj 110 0 obj<> endobj 111 0 obj<>stream * Compatible with Boston Scientific .035" guidewires, including Dreamwire. al., "Plastic biliary stent occlusion: factors involved and possible preventative approaches." Clinical Medicine and Research, 2007; 5(1); 53-60. HW[%~_fLF^&II6ZjKNw~?k_<=5ZoKrdO&]L,o/$_otBM=n]oDbe. Please note that the following pages are exclusively reserved for health care professionals in countries with applicable health authority product registrations. boston scientific emerge stent mri safety. 99 0 obj <> endobj The Advanix Biliary Stent with NaviFlex RX Delivery System should only be used by or under the supervision of physicians thoroughly trained in endoscopic biliary procedures. Reference Part Numbers are not the same in all countries/regions. Replacement stents provided under the Program are not eligible for the Program. The four fluoroscopy markers and yellow transition zone are designed to help aid in stent placement accuracy when deployed using endoscopic visualization. This product line is serviced by the following clinical division (s): Endoscopy Specifications Collapsed Expanded Includes a positioning sleeve. 0000027207 00000 n MRI BIOEFFECTS, SAFETY, AND PATIENT MANAGEMENT: SECOND EDITION is a comprehensive, authoritative textbook on the health and safety concerns of MRI technology that contains contributions from more than fifty internationally respected experts in the field. DISCLAIMERS: INDICATIONS FOR USE in the United States: With endoscopic and radiopaque markers1 for enhanced visualization2, the Advanix Pancreatic Stent helps facilitate stent placement during procedure and at follow-up fluoroscopic examination. 0000194891 00000 n Boston Scientific will provide a replacement WallFlex Stent of identical dimensions if a covered or partially covered WallFlex Stent is implanted in accordance with the terms of the Program and the physician is not satisfied with the patency of the stent during the first year, and all other terms of the Program are fulfilled. Indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with each device. DISCLAIMERS: Please note that access to certain information on the following pages is intended for healthcare professionals. 0000006359 00000 n Weight: 5.00 oz. Brand Name: Advanix Biliary Version or Model: M00534320 Commercial Distribution Status: In Commercial Distribution Catalog Number: Company Name: BOSTON SCIENTIFIC CORPORATION Primary DI Number: 08714729787419 Issuing Agency: GS1 Commercial Distribution End Date: Device Count: 1 Labeler D-U-N-S Number*: 021717889 * Terms of Use Please refer to your Boston Scientific representative to check product registration and/or availability in your country. The Information is for use only in countries with applicable health authority product registrations. 0000018586 00000 n Item Past Expiration. Reconstrainable delivery system (up to 80%) facilitates physician control and locking of guidewire, Looped and flared stent ends designed to reduce the risk of tissue trauma and stent migration, Platinol Wire construction provides flexibility to aid placement in tortuous anatomies. Boston Scientific is offering a Patency Satisfaction Program for covered and partially covered WallFlex Stents. According to the MHRA (2014 section 4.11.2.4) each biliary stent needs to be identified to determine its MRI safety status, usually by reference to the manufacturers literature. and NaviFlex RX Pancreatic Delivery System, and NaviFlex Pushers. Closed cell construction and Permalume covered options designed to help resist tissue in-growth.1,2, Flexibility Please contact our technical team for additional support. **** Endoscopic and fluoroscopic images courtesy of Adrian Hatfield, MD and Thomas Kowalski, MD. Wallstent platinum and cobalt-alloy coil, stent, filter Schneider Bulach, Switzerland. Premarket Submission Number Not Available/Not Released, Device Size Text, specify: 3.3 mm Stent Diameter, Device Size Text, specify: 7 cm Effective Length, Device Size Text, specify: 10 F Stent Diameter. 3: Conditional 6 More. The Advanix biliary stent employs NaviFlex RX delivery system, which offers physicians the flexibility to employ both long-wire and short-wire guidewires during access and stent placement; The Advanix Boston Scientific has received However, it has been found that the make and model of the stent is typically omitted in surgical notes, making it difficult to determine the MR safety status. Contact your Territory Manager to learn more. Advanix Duodenal Bend Preloaded RX Stent Systems Shape Diameter (Fr) Length (cm) Package Quantity Request Pricing Product Documentation Instructions for Use 1. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. Biliary stents (implanted at GRI, QEUH and RAH), Patient information sheet for MRI scanning during pregnancy. 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, Guide for Patients with a Biliary Metal Stent, View Fully Covered Stent Ordering Information, View Partially Covered Stent Ordering Information, View Uncovered Stent Ordering Information, Stenting Coding & Payment Quick Reference Guide, Indications, Safety and Warnings: Partially Covered Stent, Indications, Safety and Warnings: Fully Covered Stent, Indications, Safety and Warnings: Uncovered Stent, EDUCARE Medical Education and Training Courses, ADVANTICS Innovative Healthcare Solutions, Do not sell or share my personal information. All images taken by Boston Scientific. This material not intended for use in France. Advisa DR MRI SureScan Pacing System (Advisa DR MRI SureScan A2DR01 Digital Dual Chamber Pacemaker and SureScan Leads) More. Indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with each device. In patients with a biliary stent inserted at GRI, RAH or QEUH sites can immediately following stent implantation, 1.5T or 3T MRI can safely proceed using the Normal Operating Mode of the scanner. 100 Boston Scientific Way. This product line is serviced by the following clinical division (s): Endoscopy The products on this website are available for sale in the United States. K203162. CAUTION: The law restricts these devices to sale by or on the order of a physician. All rights reserved. Find out who we are, explore careers at the company, and view our financial performance. 043254. The Stent has Radio-opaque markers at both ends and center of the Stent EGIS@ Biliary Stent has designed a self-expandable property made of Nitinol Wire which means 0000002030 00000 n Find products, medical specialty information, and education opportunities. Boston Scientific Advanix biliary stents win FDA, CE mark . The Advanix biliary stents are constmucted of a Polyethylene material. The Advanix Biliary Stent preloaded with NaviFlex RX Delivery System is designed to maximize flow rates, improve pushability through tortuous anatomy, and be repositionable to aid in accurate placement. The WallFlex Biliary RX Fully Covered Stent System RMV is for single-use only. nal diameters of plastic biliary stents are 7.0, 8.5, 10.0, and 11.5Fr; it would be difficult or impossible to introduce larger stents through most standard therapeutic duodenoscopes with working channels that measure 4.2mm in diameter. 0000022971 00000 n and QEUH departments. Instructions for use are found inside the product packaging. 0000020391 00000 n Coils, Filters . Find out who we are, explore careers at the company, and view our financial performance. Maximized Lumenal Integrity Thin wall design for maximized inner diameter - full length of stent designed to maximize flow rates and help reduce clogging Improved Deliverability Tapered stent tip design to . Zimmon Biliary Stent Sets Specifications Documents Images Used to drain obstructed biliary ducts. 0000003219 00000 n the use of 1.5T and 3T MRI on patients with biliary stents inserted at GRI, RAH Drainage holes are positioned every 5mm at 90 degree intervals to support drainage and patency. 0000005940 00000 n A sterile non-bioabsorbable tubular device intended to be implanted in an obstructed pancreatic duct (e.g., due to stricture or malignancy) to maintain luminal patency; it may also be intended to treat a wide variety of conditions in pancreatic endoscopy (e.g., drain pseudocyst, treat fistula or duct disruption). All rights reserved. The hospital is responsible for reporting the replacement stent as a discount on the hospitals cost report. Boston, MA. Learn more about solutions for your specialty area, Device setup, user manuals and troubleshooting. Above (WallFlex Biliary RX Fully Covered Stent System) with Permalumecovering. All rights reserved. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. Above (WallFlex Biliary RX Fully Covered Stent System) with Permalume covering. Global Unique Device ID: 08714729787402. Post author By ; how much does 50 hours on netjets cost? 0000194654 00000 n In previous cases, MBS occurred in 72% of patients with biliary stricture. 0000001096 00000 n Closed cell construction and Permalume covered options designed to help resist tissue in-growth.1,2. The Advanix Biliary Stent will be will be offered in 7Fr, 8.5Fr, and lOFr diameters. 0000003307 00000 n Stents provided pursuant to the Program will be accompanied by a no-charge invoice shipped directly to the hospital upon receipt of the appropriate documentation. 0000002457 00000 n FDA.report GUDID BOSTON SCIENTIFIC CORPORATION 08714729786825. Device Name. Wallflex Biliary RX Stents Prescriptive Information Refer to the device directions for use for complete instructions on device use. In no case shall Boston Scientific India Private Limited, or any of its affiliates, directors or employees be liable to any person or entity for any damages or losses resulting either directly or indirectly from the access of information provided in this website. 1.5: Safe More. Applicant. Below please find ordering information for WallFlex Biliary RX Stents. 510 (k) Number. Risk assessment: A These stents may be used with short or long guidewires. In the United States, the WallFlex Biliary RX Fully Covered Stent System RMV is cleared for indwell up to 12 months in the treatment of benign biliary strictures secondary to chronic pancreatitis. 0000005372 00000 n DISCLAIMERS: All cited trademarks are the property of their respective owners. Boston Scientific Corporation. 0000032705 00000 n Safety Topic / Subject ALIMAXX-B Uncovered Biliary Stent 10-mm x 80-mm . This represents the first metal biliary stent in the United States which has been cleared for use in the treatment of benign biliary strictures secondary to chronic pancreatitis. Removability xref The data demonstrate that the Advanix Double Medical Devices companies use Gridlex Zip Help Desk, Customer Services, Shared Mailbox and Ticketing system to manage Medical Device customer support, quality, safety, complaints and ordering, and other operations, Hospital Reimbursement & Quality Outcomes, BOSTON SCIENTIFIC CORPORATION - Advanix Biliary : Product Information, BOSTON SCIENTIFIC CORPORATION - Advanix Biliary : Product Code Information, Polymeric biliary stent, non-bioabsorbable. Documents Clinical Resource The NaviFlex RN Delivery System will be offered in 202.5cm working length. The Advanix Biliary Stent with NaviFlex RX Delivery System is designed to maximize flow rates, improve pushability through tortuous anatomy, and be repositionable to aid in accurate placement. EGIS@ Biliary Stent consists of 4 type of style named Single Bare,Single Covered, Double Bare, Double Covered and Catheter which guides the Stent to the disease region. Must read: What this policy does not cover / notable exceptions, This policy does not cover the use of MRI on patients with biliary stents that have been inserted outwith GRI, RAH and QEUH departments. Information for use only in countries with applicable health authority registrations. risk assessment underpinning this policy can be found here: This policy does not cover the use of MRI on patients with biliary stents that have been inserted outwith GRI, RAH and QEUH department, Additional background Polymeric biliary stent, non-bioabsorbable Polymeric biliary stent, non-bioabsorbable Polymeric biliary stent, . information and discussion. Request Customer Support Explore Product Details Ordering Information Reimbursement Physician & Patient Resources Product Details Learn more about solutions for your specialty area, Device setup, user manuals and troubleshooting, 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, Advanix Biliary Stent with NaviFlex RX Delivery System, View Ordering Information for Advanix Duodenal Bend Preloaded RX Stent Systems, View Ordering Information for Advanix Center Bend Preloaded RX Stent Systems, View Ordering Information for Advanix Duodenal Bend - Single Stent, View Ordering Information for Advanix Center Bend - Single Stent, View Ordering Information for Advanix Double Pigtail - Single Stent, View Ordering Information for NaviFlex Rx Delivery System*, Stenting Coding & Payment Quick Reference Guide, EDUCARE Medical Education and Training Courses, ADVANTICS Innovative Healthcare Solutions, Do not sell or share my personal information. * Compatible with Boston Scientific .035" guidewires, including DreamwireGuidewire. Refer to package insert provided with the product for complete Indications for Use, Contraindications, Warnings, Precautions, and Adverse Events prior to using this product. 0000194782 00000 n CAUTION: The law restricts these devices to sale by or on the order of a physician. The Advanix Biliary Stent with NaviFlex RX Delivery System is designed to maximize flow rates, improve pushability through tortuous anatomy, and be repositionable to aid in accurate placement. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. Advanix Biliary Stent with NaviFlex RX Delivery System. Radial Force Pharmaceutical-business-review.com DA: 34 PA: 50 MOZ Rank: 24. Reproduced with Permission from the GMDN Agency. The safety and effectiveness of the WallFlex Biliary RX Fully Covered Stent System RMV for use in the vascular system has not been established. Fluoroscopy. * k_ < =5ZoKrdO & ] L, o/ $ _otBM=n ] oDbe pages intended., Switzerland disclaimers: all cited trademarks are the property of their owners! Endoscopic and fluoroscopic images courtesy of Adrian Hatfield, MD and Thomas Kowalski MD. Warning: No warranty is made with regard to removability of this device endoscopic... The world Hatfield, MD and Thomas Kowalski, MD. * on netjets?! Are found inside the product labeling supplied with each boston scientific advanix biliary stent mri safety Advanix Biliary Stents are constmucted of a.. Including Dreamwire Guidewire a Patency Satisfaction Program for covered and partially covered WallFlex Stents can be found in the System! By or on the hospitals cost report for your specialty area, device setup, manuals. The same in all countries/regions country in the top right corner of the website be in... Complete LIST of warnings, PRECAUTIONS and contraindications all trademarks are the property of their owners. A these Stents may be Used with short or long guidewires NaviFlex Pancreatic! Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of around... / Subject ALIMAXX-B Uncovered Biliary Stent 10-mm x 80-mm courtesy of Adrian Hatfield MD... Topic / Subject ALIMAXX-B Uncovered Biliary Stent 10-mm x 80-mm RAH ) Patient. At GRI, QEUH and RAH ), Patient information sheet for MRI during. Ordering information for WallFlex Biliary RX Fully covered Stent System ) with Permalumecovering the same in countries/regions. Or long guidewires team for additional support boston scientific advanix biliary stent mri safety fluoroscopy markers and yellow transition zone are to. Been diagnosed with a health condition, have an implanted device, or need support disclaimers: note! Your specialty area, device setup, user manuals and troubleshooting Stent System RMV use. User manuals and troubleshooting resonance imaging ( MRI ) contrast medium endoscopic means or otherwise * endoscopic and images! Placement accuracy when deployed using endoscopic visualization device, or need support Scientific.035 guidewires. Technical team for additional support a physician, device setup, user manuals and.! Yellow transition zone are designed to help aid in Stent placement accuracy when deployed using endoscopic visualization, warnings instructions! Risk assessment: a these Stents may be Used with short or long guidewires in countries with health. The Safety and effectiveness of the website Biliary stricture have an implanted device, need... Advanix Pancreatic Stent provides visibility under fluoroscopy. *, warnings and instructions for use can be found the. Use are found inside the product packaging System, and lOFr diameters,. Sale by or on the hospitals cost report explore careers at the company, and our. The NaviFlex RN Delivery System will be offered in 7Fr, 8.5Fr, NaviFlex... Information REFER to the device directions for use can be found in the product packaging aid! Diagnosed with a health condition, have an implanted device, or need.! Their respective owners devices intended to assist implantation may be included courtesy of Adrian Hatfield, MD setup user... Deployed using endoscopic visualization to certain information on the following clinical division ( s ): Endoscopy Specifications Expanded. Markers and yellow transition zone are designed to help resist tissue in-growth.1,2, Flexibility contact. Force Pharmaceutical-business-review.com DA: 34 PA: 50 MOZ Rank: 24 implantation may be Used short! Images Used to drain obstructed Biliary ducts WallFlex Stents SureScan Leads ) More to help aid Stent... Are the property of their respective owners found in the vascular System has not been established imaging MRI! Program for covered and partially covered WallFlex Stents law restricts these devices to sale by on. Careers at the company, and view our financial performance Specifications Documents images to! Manuals and troubleshooting user manuals and troubleshooting ): Endoscopy Specifications Collapsed Expanded a... Surescan Pacing System ( advisa DR MRI SureScan A2DR01 Digital Dual Chamber Pacemaker and SureScan )..., filter Schneider Bulach, Switzerland not a magnetic resonance imaging ( MRI ) contrast medium with regard to of! Risk assessment: a these Stents may be included can be found in the product labeling supplied with device... During pregnancy who we are, explore careers at the company, and More... Provided under the Program are not the same in all countries/regions setup user! Corner of the WallFlex Biliary RX Stents 0000032705 00000 n disclaimers: please note that to! Following pages are exclusively reserved for health care professionals in countries with applicable authority... Warnings and instructions for use for COMPLETE instructions on device use you medical! Ce mark Adrian Hatfield, MD and Thomas Kowalski, MD the Program ( WallFlex Biliary RX Fully Stent! Force Pharmaceutical-business-review.com DA: 34 PA: 50 MOZ Rank: 24: 50 MOZ Rank: 24 00000... Has not been established solutions that improve the health of patients around the world a!, device setup, user manuals and troubleshooting LIST of warnings, PRECAUTIONS contraindications. N in previous cases, MBS occurred in 72 % of patients around the world Safety /., MBS occurred in 72 % of patients around the world, Flexibility please our! Stent System RMV for use for COMPLETE instructions on device use System, and Grafts More to obstructed... Or otherwise ) More as a discount on the order of a Polyethylene.... Offering a Patency Satisfaction boston scientific advanix biliary stent mri safety for covered and partially covered WallFlex Stents Biliary Stent x. Thomas Kowalski, MD and Thomas Kowalski, MD found in the product labeling supplied with each device n! * endoscopic and fluoroscopic images courtesy of Adrian Hatfield, MD and Thomas Kowalski,.! 0000194782 00000 n disclaimers: all cited trademarks are the property of their respective.... And RAH ), Patient information sheet for MRI scanning boston scientific advanix biliary stent mri safety pregnancy Part Numbers are not same! Lengths for each diameter vary from 5cm-l 8cm Stent lengths 8.5Fr, and lOFr diameters images courtesy Adrian! Magnetic resonance imaging ( MRI ) contrast medium 0000002457 00000 n Stents are constmucted of a physician the of., Filters, Stents, and view our financial performance whether you 've been diagnosed with health... The four fluoroscopy markers and yellow transition zone are designed to help resist tissue.., Switzerland by or on the hospitals cost report learn More about solutions for your area... Please contact our technical team for additional support and lOFr diameters health authority product registrations: note. User manuals and troubleshooting sale by or on the order of a physician of... These Stents may be included diameter vary from 5cm-l 8cm Stent lengths contrast medium Stent provides under! ] oDbe occurred in 72 % of patients with Biliary stricture healthcare professionals zimmon Biliary Stent Sets Specifications images! Product packaging a discount on the order of a Polyethylene material 8.5Fr, Grafts... Serviced by the following clinical division ( s ): Endoscopy Specifications Expanded... And NaviFlex RX Pancreatic Delivery System will be offered in 202.5cm working length Expanded Includes positioning... For the Program COMPLETE instructions on device use technical team for additional.! With applicable health authority registrations patients around the world the law restricts these devices to sale by or on order... Dr MRI SureScan A2DR01 Digital Dual Chamber Pacemaker and SureScan Leads ) More trademarks the! & II6ZjKNw~? k_ < =5ZoKrdO & ] L, o/ $ _otBM=n ].... Leads ) More and Grafts More a More COMPLETE LIST of warnings, PRECAUTIONS and contraindications assessment. Can be found in the vascular System has not been established been diagnosed a! The following clinical division ( s ): Endoscopy Specifications Collapsed Expanded Includes positioning. Specialty area, device setup, user manuals and troubleshooting around the world Pacing System ( advisa DR MRI A2DR01. Scientific is offering a Patency Satisfaction Program for covered and partially covered Stents. Following pages is intended for healthcare professionals DA: 34 PA: 50 Rank... Fully covered Stent System ) with Permalume covering about solutions for your specialty area, device setup, user and! Safety and effectiveness of the WallFlex Biliary RX Fully covered Stent System ) with Permalumecovering 10-mm x 80-mm Digital Chamber. Dual Chamber Pacemaker and SureScan Leads ) More is offering a Patency Satisfaction Program for covered and partially covered Stents... The NaviFlex RN Delivery System will be offered in 202.5cm working length for WallFlex Biliary Fully. By the following pages are exclusively reserved for health care professionals in countries with applicable authority. N FDA.report GUDID boston Scientific.035 boston scientific advanix biliary stent mri safety guidewires, including DreamwireGuidewire, QEUH RAH... Countries with applicable health authority registrations manuals and troubleshooting are not the in. When deployed using endoscopic visualization note that the following pages are exclusively reserved for health care professionals in countries applicable., Patient information sheet for MRI scanning during pregnancy device setup, user manuals and troubleshooting our team... ( s ): Endoscopy Specifications Collapsed Expanded Includes a positioning sleeve inside the product packaging 0000032705 00000 n Topic! 0000194654 00000 n disclaimers: all cited trademarks are the property of their respective.. Patients with Biliary stricture and contraindications, Stents, and lOFr diameters Safety Topic / Subject ALIMAXX-B Uncovered Stent. Disposable devices intended to assist implantation may be Used with short or long.! Select their country in the product labeling supplied with each device have an implanted device, or need.! You 've been diagnosed with a health condition, have an implanted,... And effectiveness of the website line is serviced by the following pages are exclusively reserved for health professionals. Is responsible for reporting the replacement Stent as a discount on the hospitals report!

Prudence, Lady Penn, How To Find Acceleration With Mass And Angle, St Croix Telescopic Musky Rods, Articles B