Boston Scientific 3422 Advanix Biliary Stent w Naviflex RX Delivery System is designed to maximize flow rates, improve pushability through tortuous anatomy, and be repositionable to aid in accurate placement. 0000194722 00000 n 0000018586 00000 n WALLFLEX Biliary RX Fully Covered Stent Electro-polished Nitinol stent Moderate radial force and low axial force, which prevents compression and migration Reported migrations ranging from 0–1 .4% compared to migration rates up to 13% for the BOSTON SCIENTIFIC WALLFLEX Biliary RX Fully Covered Stent A durable, nonporous ePTFE/FEP end-to-end liner �` �X� 0000003169 00000 n x�b``�c``ig`e`bd@ A6v��繯[*�/``����� ���j��[r��c Global Unique Device ID: 08714729787402. Safety Topic / Subject Alignment Rod BioTex, Inc., biotexmedical.com. trailer About Boston Scientific Boston Scientific is a worldwide developer, manufacturer and marketer of medical devices whose products are used in … ... Coils, Filters, Stents, and Grafts More... 2D Helical, 35 Fibered Platinum Coil. Description. 0000006584 00000 n 0000002457 00000 n 0000194891 00000 n Biliary Stent Sets. 0000001521 00000 n 0000005940 00000 n Advanix Biliary Stent 7Fr center bend, double pig tail, and duodenal bend. Safety Topic / Subject Cortical bone screw small (titanium alloy) orthopedic implant Zimmer ... Boston Scientific, www.bostonscientific.com. Stents, drains and dilators for the biliary ducts - Product Code FGE: Product: Advanix Pancreatic Stent, Straight Leading Barb, 10F x 6cm UPN: M00536640: Code Information: Lot Codes: 21973220 22522254 23837823 Recalling Firm/ Manufacturer: Boston Scientific Corporation 300 Boston Scientific Way Marlborough MA 01752-1291 Indications, Safety, and Warnings - Pushers. Advanix ™BiliaryStent with NaviFlex ™ RX Delivery System Why place a stent? Boston Scientific Announces FDA Clearance and CE Mark Approval for Advanix™ Biliary Stents Latest innovation in plastic biliary stent technology includes features for enhanced deliverability, efficiency and procedural control $599.00 box of 1 - Boston Scientific # M00570370 - Boston Scientific WallFlex RX Fully Covered Biliary Stent: 10mm x 60mm Device Name: Biliary Stent with NaviflexTM RX Delivery System. Floor polishers are poor MRI system cleaners! Established soft knitted, flexible stent available in proximal release which can aid in stent placement in proximal strictures of the esophagus WallFlex TM Esophageal Stent (partially covered) Seeks to deliver luminal patency through flexibility and control designed to traverse tight strictures. AccessGUDID - Advanix™ Biliary (08714729787426)- Biliary Stent with NaviflexTM RX Delivery System Shape Memory Medical, Inc., www.shapemem.com. 0000027207 00000 n 0000016595 00000 n Boston Scientific Announces FDA Clearance and CE Mark Approval for Advanix™ Biliary Stents Latest innovation in plastic biliary stent technology includes features for enhanced deliverability, efficiency and procedural control Covered WallFlex Biliary RX Stent Boston Scientific, www.bostonscientific.com. The device offers a nonsurgical treatment for biliary strictures caused by prior surgical procedures, biliary stones, chronic pancreatitis and various types of cancer. In Stock! 0000014680 00000 n 0000022971 00000 n Boston Scientific 3226 Advanix Biliary Double Pigtail Biliary Stnt 10Fr x 5 cm Item Past Expiration. In Stock! The WallFlex Biliary RX Fully Covered Stent System RMV is currently the only biliary metal stent in the U.S. for indwell up to 12 months in the treatment of benign biliary strictures secondary to chronic pancreatitis. 138 0 obj<>stream $40.00) OEM: Boston Scientific; Model #: 3735; Year: 2016 Size: 4Fr x ... Advanix™ Center Bend Biliary Stent-w-NaviFlex™ RX Delivery System - 10Fr x 5cm $40.00. Uncovered WallFlex Biliary RX Stent System Boston Scientific Corporation Marlborough, MA. Ampco Safety Tools Garland, TX. The Advanix Biliary Stent and NaviFlex RX Delivery System are available in a variety of sizes and shapes to accommodate both malignant and benign biliary strictures, distinct patient anatomies and physician preferences. 0000005372 00000 n REFERENCE STATEMENT. We understand that you need dependable advanced stent technologies optimized for patient care. 0000006218 00000 n 0000002030 00000 n Polymeric biliary stent, non-bioabsorbable. 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). $599.00 box of 1 - Boston Scientific # M00570370 - Boston Scientific WallFlex RX Fully Covered Biliary Stent: 10mm x 60mm 0000003412 00000 n Boston Scientific 3226 Advanix Biliary Double Pigtail Biliary Stnt 10Fr x 5 cm Item Past Expiration. An office chair was in the wrong place - at ANY time! Boston Scientific has received 510(k) clearance and CE Marking for its Advanix biliary plastic stent. Version (Model) Number: M00534310. Boston Scientific Announces FDA Clearance and CE Mark Approval for Advanix™ Biliary Stents Latest innovation in plastic biliary stent technology includes features for enhanced deliverability, efficiency and procedural control Video content includes procedural footage, case studies, animations, patient testimonials, and more. 0000031716 00000 n NATICK, Mass., March 22, 2012 /PRNewswire/ -- Boston Scientific Corporation (NYSE: BSX) announces the U.S. and international launch of the WallFlex ® Biliary Transhepatic Stent System. <]>> Liberte' (Liberte) Coronary Stent Liberte Bare-Metal Coronary Stent Boston Scientific, www.bostonscientific.com %%EOF NaviFlex™ RX Delivery System includes an ergonomic handle lock to adjust guide catheter length. Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01752 JUL 2 3 2010 Telephone: 508-683-4347 Fax: 508-683-5939 Contact: Elena Nieves Senior Regulatory Affairs Specialist Date Prepared: May 10, 2010 2. Company Name: BOSTON SCIENTIFIC CORPORATION. About Boston Scientific GMDN Preferred Term Name GMDN Definition; Polymeric biliary stent, non-bioabsorbable This in-service video provides step-by-step instructions for placing the Advanix Pancreatic Stent using the NaviFlex RX Delivery System. 0000003219 00000 n Indications: The Visi-Pro™ balloon-expandable peripheral stent system is indicated for improving luminal diameter in patients with atherosclerotic disease of the common and/or external iliac arteries up to 100 mm in length, with a reference vessel diameter of 5 to 10 mm. Proposed Device: Trade Name: AdvaniXTm Biliary Stent with NaviFleXTm RX Delivery System Classification Name: AccessGUDID - Advanix™ Biliary (08714729787426)- Biliary Stent with NaviflexTM RX Delivery System 0000194996 00000 n Boston Scientific 3422 Advanix Biliary Stent w Naviflex RX Delivery System. The Advanix Biliary Stent and NaviFlex RX Delivery System are available in a variety of sizes and shapes to accommodate both malignant and benign biliary strictures, distinct patient anatomies and physician preferences. About Boston Scientific 4. 0000002525 00000 n %PDF-1.4 %���� Boston Scientific Announces FDA Clearance and CE Mark Approval for Advanix™ Biliary Stents. GMDN Preferred Term Name GMDN Definition; Polymeric biliary stent, non-bioabsorbable Advanix™ Biliary Stent - Boston Scientific. 0000003127 00000 n Non-clinical testing and MRI simulations were performed to evaluate the entire family (i. 0000002795 00000 n 0000020391 00000 n Bostonscientific.com Contact Us Disclaimer. Double Pigtail Ureteral Stent ... Boston, MA. 0000001096 00000 n Ships Today! Boston Scientific, www.bostonscientific.com . Bostonscientific.com 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. NATICK, Mass., March 22, 2012 /PRNewswire/ -- Boston Scientific Corporation (NYSE: BSX) announces the U.S. and international launch of the WallFlex ® Biliary Transhepatic Stent System. 7F x 9 cm. MR imaging within these conditions may be performed immediately following the implantation of the stent. Dental Implants, Devices, and Materials More... ALIMAXX-B Covered Biliary Stent 10-mm x 80-mm Nickel Titanium with a silicone covering Alveolus, Inc. Charlotte, NC. 0000000016 00000 n 0000032476 00000 n * ... Safety, and Warnings - Delivery System . $20.00 each - Boston Scientific # M00534210 - Boston Scientific Advanix Duodenal Bend Pre-loaded Rx Biliary Stent: 7F x 7cm 99 40 Device Name: Biliary Stent with NaviflexTM RX Delivery System. startxref In Stock! 0000006359 00000 n 0000032705 00000 n TrelliX Embolic Coil System, All Versions. Access our instructions for use and product manuals library. 99 0 obj <> endobj 0000005619 00000 n Double Pigtail Ureteral Stent Hydrophilic Coated Polyurethane Gyrus ACMI, Inc. 0000003307 00000 n 0000032536 00000 n Endoscopically-placed stents are a clinically effective treatment for biliary �`a�b�i`� 2�"ȾHb����? Duodenal Bend Preloaded. 0000010863 00000 n Used to drain obstructed biliary ducts. Boston Scientific Announces FDA Clearance and CE Mark Approval for Advanix™ Biliary Stents Latest innovation in plastic biliary stent technology includes features for enhanced deliverability, efficiency and procedural control 0 You need a trusted partner with over 20 years of investment in clinical research and development and a commitment to the highest standards of quality. Advanix™ Pancreatic Stent Kit/ Single pigtail Stent-NO leading Barb - 4Fr x 3cm Boston Scientific. Brand Name: Advanix™ Biliary. H��W[�%�~�_��fLF����^&ƻ�I��İ��I6���������Zj���K��N�w�~������?����߳��k��_<=�5Z��������oK��rdO�&���]�L��,����o/$�_��o����t����BM���=�n�]�o��D����Ż�b���e�. Radiopaque marker on leading end of the Advanix Pancreatic Stent provides visibility under fluoroscopy. MR imaging within these conditions may be performed immediately following the implantation of the stent. Disposable devices intended to assist implantation may be included. The covered WallFlex™ Biliary RX Stent should not migrate in this Magnetic Resonance Imaging (MRI) environment, as magnetic force and torque in the non-clinical tests was less than the values exerted by the earth’s gravity. 0000001584 00000 n with stents are routinely imaged at 1.5T and 3T where the safety and MRI compatibility of some of these devices have been previously investigated [1]. 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 MRI Safety Information. 0000008839 00000 n 0000194782 00000 n Premarket Submission Number Not Available/Not Released, Device Size Text, specify: 10 F Stent Diameter, Device Size Text, specify: 15 cm Effective Length, Device Size Text, specify: 3.3 mm Stent Diameter. With the availability of ultra high field scanners, there is now necessity to perform MRI safety and compatibility studies at these higher fields. The products on this website are available for sale in the United States. Company Name: BOSTON SCIENTIFIC CORPORATION. For Healthcare Professionals For specific information about a Boston Scientific product's MR safety status, please refer to the product's Instructions For Use or contact Boston Scientific Customer Service. Safety Topic / Subject Ultraflex Tracheobronchial Stent Boston Scientific, www.bostonscientific.com. MAGNETIC RESONANCE IMAGING (MRI) SAFETY INFORMATION  Non‐clinical testing has demonstrated that WALLSTENT TIPS is MR Conditional for single and overlapping lengths up to 94 mm. Reproduced with Permission from the GMDN Agency. Boston Scientific Corporation has demonstrated that the proposed AdvaniXTM Biliary Stent with NaviFleXTm RX Delivery System is substantially equivalent to Boston Scientific Corporation's … AccessGUDID - Advanix™ Biliary (08714729786764)- Biliary Stent. The covered WallFlex™ Biliary RX Stent should not migrate in this Magnetic Resonance Imaging (MRI) environment, as magnetic force and torque in the non-clinical tests was less than the values exerted by the earth’s gravity. This in-service video provides step-by-step instructions for placing the Advanix Pancreatic Stent using the NaviFlex RX Delivery System. 0000006007 00000 n The covered WallFlex™ Biliary RX Stent should not migrate in this Magnetic Resonance Imaging (MRI) ... ©2017 Boston Scientific Corporation or its affiliates. ... Get Email Updates Top. xref Brand Name: Advanix™ Biliary. MRI Safety Information. GMDN Preferred Term Name GMDN Definition; Polymeric biliary stent, non-bioabsorbable 0000012830 00000 n Biliary RX Stents Fully covered stent is designed for removal up to 12 months post-placement. MR imaging within these conditions may be performed immediately following the implantation of the stent. Ships Today! Stenting in a post-operative biliary fistula or leak Multi-stenting in an anastomotic stricture post orthotopic liver transplant The Endoscopy Channel provides educational videos for physicians delivered by physicians. 032148 032148 Version (Model) Number: M00534310. al., “Plastic biliary stent occlusion: factors involved and possible preventative approaches.” Clinical Medicine and Research, 2007; 5(1); 53-60. For products available in other countries, please choose one of our other websites from the region selector at the top of the site or contact your local Cook Medical representative. The covered WallFlex™ Biliary RX Stent should not migrate in this Magnetic Resonance Imaging (MRI) environment, as magnetic force and torque in the non-clinical tests was less than the values exerted by the earth’s gravity. The safety and effectiveness of the WallFlex Biliary RX Stent System for use in the vascular system have not been established. Ships Today! An office chair was in the wrong place - at ANY time! A steel oxygen tank is never permitted inside of the MRI system room. A steel oxygen tank is never permitted inside of the MRI system room. GMDN Names and Definitions: © Copyright GMDN Agency 2015. advanix double pigtail biliary stent: BOSTON SCIENTIFIC CORP. K101786: 07/23/2010 extractor pro rx retrieval ballons, extractor pro xl retrieval ballons, extractor pro dl retrieval ballons model m005470: BOSTON SCIENTIFIC CORP. K102082: 08/23/2010 10mm x 40mm uncovered wallflex billiary rx stent system, model m00570890: BOSTON SCIENTIFIC CORP. 0000006770 00000 n Metal Expandable Biliary Stents - Premarket Notification (510(k)) Submissions Guidance for Industry and . Nexus Embolization Coil Nexus X-10-20-T10-TC Platinum-Iridium, Nitinol Micro Therapeutics, Inc. Irvine, CA AccessGUDID - Advanix™ Biliary (08714729786740)- Biliary Stent. Food and Drug Administration Staff . GO������&�E�*=~+���Q�t��U7[�X�;�!��,���[�%�aA�q�/�w�d�*='� ��(((���1^III�8-����gR��A�P-܍@�����U�� ,�� Đ� !��� Š� � �`�n`� ���,��� LK�tp2ȯa���С�Aօ}.��8v3ln`T`�WQ��b�0�3�`X`{�a CtÝ ,O�ְ-PJ`t2x>0�0010800��ׁ! 0000194654 00000 n Boston Scientific Corporation ... Oct 21, 2010. Advanix™ Biliary Stent - Boston Scientific. According to the complainant, during stent deployment, the introducer separated from the pull wire. It was reported to boston scientific corporation that an advanix preloaded biliary stent was used during an endoscopic retrograde cholangiopancreatography (ercp) procedure in the common bile duct (cbd) performed on (b)(6) 2013. Donelli, G, MD, et. The safety and effectiveness of this device for use in the vascular system has not been established. Floor polishers are poor MRI system cleaners! A sterile non-bioabsorbable tubular device intended to be implanted in an obstructed biliary duct (e.g., common bile duct) to maintain luminal patency. AccessGUDID - Advanix™ Biliary (08714729787013)- Biliary Stent. Global Unique Device ID: 08714729787402. 0000002593 00000 n For health care professionals in EUROPE excepted those practicing in France as the following pages are intended to all International health care professionals and are not in compliance with the French Advertising law N°2011-2012 dated 29th December 2011 article 34. WallFlex Enteral Duodenal Stent with Anchor Lock Delivery System Nitinol stent Boston Scientific Natick, MA