J Assoc Physicians India. Cerebrospinal Fluid (CSF) Shunt Valves and Accessories More. The PALMAZ GENESIS Peripheral Stent family is designed according to the PALMAZ Stent heritage with one piece laser cut stainless steel slotted tube (no welds) and a closed-cell design. Most of this owes to healing time more than inherent dangers, though. For over half a century, Cordis has connected and collaborated across the industry, with a mission to invent better ways to serve clinicians and their collaborators. Nienaber CA, Akin I, Schneider S, Senges J, Fetsch T, Tebbe U, Willich SN, Stumpf J, Sabin GV, Silber S, Richardt G, Kuck KH; DES.DE Study Group. Our essays are NOT intended to be forwarded as finalized work as it is only strictly meant to be used for research and study purposes. The delivery system consists mainly of an inner shaft and an outer sheath with radiopaque markers, and a Tuohy . Cordis Corporation is recalling their Precise PRO Rx US . 1 osp1ta an d 0 u t -0-f H OSpl 'tal (t . The card should include the phone number of both the surgeon who performed the implant and the patients regular physician. As we celebrate one year of independence, we are even more proud than we were 62 years ago to stand behind the heroes that allow us all to be truly free at heart. These stents have an improved scaffolding in a bend, smooth transition from stent to balloon and an excellent stent retention. CONTROL Self-Expanding Nitinol Stent, One piece laser cut stainless steel slotted tube (no welds), Laser cut slotted tube for device integrity (no welds), S shaped FlexSegments for minimal foreshortening, excellent contourability*, pre-deployed flexibility and improved scaffolding in a bend, Lengths of delivery system: 80 and 135 cm, Metal introducer tube included in the package, N shaped FlexSegments for minimal foreshortening, excellent contourability*, pre-deployed flexibility and improved scaffolding in a bend. Cookie Consent, RAIN Sheath Transradial Thin-Walled Introducer, Universal Shapes, INFINITI and SUPER TORQUE Plus Diagnostic Catheters, S.M.A.R.T. Closed-cell design They have an improved scaffolding in a bend, smooth transition from stent to balloon and an excellent stent retention. * This website contains information on products for a wide range of countries. 408.273.3700 Rofo Fortschr Geb Rontgenstr Neuen Bildgeb Verfahr 2004;176:731-8. These stents also are generally safe during an MRI, but more caution may be needed to ensure that the magnetic activity doesnt change the drug distribution schedule. Metallic objects placed in the body can pose problems for MRI scans, which use a strong magnetic field and pulses of radio waves to see inside the body. Commercial Distribution End Date: Cordis Announces Acquisition of MedAlliance, Positioning Itself for Market Leadership in Drug-Eluting Balloon Technology, Multi-center study to evaluate safety and efficacy of S.M.A.R.T. Herz. Stainless steel Safety of magnetic resonance imaging in patients with cardiovascular devices: An American Heart Association scientific statement from the Committee on Diagnostic and Interventional Cardiac Catheterization. Commercial Distribution End Date: offshore control room operator jobs near leeds; oil extractor pump near berlin; whirlpool duet washer dryer combo; upgrading cyberpowerpc; best wood flooring over radiant heat Safety of early cardiac magnetic resonance imaging in acute myocardial infarction patients with stents. This site is Exclusively Sponsored by BRACCO, Orthopedic Implants, Materials, and Devices, Intrauterine Contraceptive Devices (IUDs) and Other Contraceptive Devices. J Magn Reson Imaging 2002;16:721-732. A stents main goal is to help keep the major arteries open so that blood can quickly and easily flow through them. MRI radiographers and healthcare professionals in the UK have been asked to 'read and understand the updated compatibility information' and share with relevant people in their organisations. 2004 Mar;29(2):181-6. doi: 10.1007/s00059-004-2560-x. We have reviewed and classified all the major stents currently available world-wide and discussed their interaction with MRI through their ferro-magneticity. Shellock R & D Services, Inc. email: Frank.ShellockREMOVE@MRIsafety.com. A detailed description of each of the two components of the CORDIS ENTERPRISE T M Vascular Reconstruction Device and Delivery System follows: Vascular Reconstruction Device (Stent) -The Stent has a tubular mesh structure laser cut from Nitinol. Privacy Statement (22) Tejedor-Viuela P, et al. PALMAZ GENESIS Peripheral Stent The CYPHER Sirolimus-eluting Coronary Stent (CYPHER Stent) is a combination product comprised of two regulated components: a device (a stent system) and a drug product (a formulation of sirolimus in a polymer coating). Radiology 2006;240:674-680. (7) Gerber TC, et al. MR safety at 3-Tesla: Bare metal and drug eluting coronary artery stents. The Cordis PALMAZ GENESIS Peripheral Stent on CORDIS AMIIA.014 Delivery System is intended for use in the treatment of atherosclerotic disease of peripheral arteries below the aortic arch following suboptimal percutaneous angioplasty (PTA) of a de novo ; Is the Palmaz Schatz stent safe on a MRI? and PRECISE stents. Several studies have shown that an MRI can be performed safely within a day of stent implantation, though many radiologists advise waiting several weeks before undergoing this or any related procedure. 3: Conditional 6 More. Importantly, there has never been an adverse event reported in association with performing MRI in patients with these particular implants. For Additional Information Contact. Through a series of procedurally based coronary and endovascular modules, users can expand their skills and master Cordis tools. S shaped FlexSegments for minimal foreshortening, excellent contourability*, pre-deployed flexibility and improved scaffolding in a bend Privacy Statement This website contains information on products for a wide range of countries. 877-338-4235. One piece laser cut stainless steel slotted tube (no welds) This is a European Website and its content is not compliant with French advertising regulation law n 2011-2012 du 29 December 2011, article 34. Am J Cardiol 2005;96:366-8. with your question or order, or call us at 0080084477384. Reason for Recall. Commercial Distribution Status: In Commercial Distribution. (2) Patients with all commercially available coronary artery stents can undergo MRI immediately after placement of these implants. MR procedures: Biologic effects, safety, and patient care. Acute myocardial infarction: Safety of cardiac MR imaging after percutaneous revascularization with stents. Device Family, Partial and Total Prosthesis; FOIA A. Stents are metallic cages that hold open a coronary artery after angioplasty. PALMAZ GENESIS Stent on the OPTA PRO Catheter (Medium) Stainless steel One piece laser cut stainless steel slotted tube (no welds) Closed-cell design Laser cut slotted tube for device integrity (no welds) As a result, it may contain information about products not available in your country. Review of safety reports of cardiac MR-imaging in patients with recently implanted coronary artery stents at various field strengths. The site is secure. Cordis PALMAZ Corinthian 1998-1999 Cordis PALMAZ Corinthian IQ 1999-2000 Cordis PALMAZ Genesis 2001-2002 No longer commercially available L605 (Co/Cr) MP35N (Co/Cr) 316L (SS) Cobalt 51% 35% NA Chromium 20% 20% 18% Tungsten 15% NA NA Iron 1,5% 1% 63% Nickel 10% 35% 14% Based on benchtop testing, Cordis data on file, 2005. Learn or test yourself. One piece laser cut stainless steel slotted tube (no welds) Clinical safety of cardiac magnetic resonance imaging at 3 T early after stent placement for acute myocardial infarction. Is It Safe to Combine Trazodone and Sertraline? Cordis is making a difference. Specifically, the Instruction for . Concerns Over Magnetic Field The question of whether having an MRI with a stent is safe usually stems from a fear that the magnetic field generated by the MRI will displace the stent. This system features a smaller access profile than any radial sheath, and compatibility with a variety of guiding catheters.1 Compared to conventional radial sheaths. A field safety notice has been issued to correct a labelling issue by Cordis for self-expanding stents under MRI, specifically for SMART and PRECISE. For more information, please contact your local Cordis representative. Guidelines for the Management of Patients with Coronary Artery Stents Referred for MRI Examinations, Whole body averaged specific absorption rate (SAR) of 2-W/kg (i.e., operating in the Normal Operating Mode for the MR system), Maximum imaging time, 15 minutes per pulse sequence (multiple pulse sequences per patient are allowed). 0 9 month s ) Description of Event : SMART Terms and Conditions Current status]. (9) Jehl J, et al. Furthermore FlexSegments and Cordis Nesting technology ensure predeployed flexibility, a minimum foreshortening and an excellent contourability*. Conditional 6 More. Select a Region Long-term safety of cardiac magnetic resonance imaging performed in the first few days after bare-metal stent implantation. Please understand that it is not intended to provide information to the general public. At the center of our passion for advancing cardiovascular and endovascular health are the clinicians and collaborators on the frontlines. Non-emergency MRIs for patients with stents may delayed while the MRI facility consults with the patients physicians to confirm the safety of the procedure. GMDN Preferred Term Name GMDN Definition; Peripheral artery stent, bare-metal A non-bioabsorbable tubular device intended to be implanted in a peripheral artery (excludes aorta, carotid, coronary, and intracranial arteries) to indefinitely maintain patency and improve luminal diameter in patients with atherosclerotic disease, or following the recanalization of a total occlusion; it might . Bookshelf They have an improved scaffolding in a bend, smooth transition from stent to balloon and an excellent stent retention. Pre-mounted PALMAZ GENESIS Stent (Large) 1 / 2 Pages Catalog excerpts .035" Over-the-wire System PALMAZ GENESIS on OPTA Pro (Large) PALMAZ* Genesis" Rated burst Pressure: 10 atm Nominai pressure: s atm designed for life Ordering Information Cordis. Company Name: CORDIS CORPORATION. To avoid such a delay in emergency situations, a patient is advised to keep a card with him explaining what devices he has implanted. When the item is expired must be used for educational, training, veterinary or non-clinical research purposes only. (2) Shellock FG, Woods TO, Crues JV. This site needs JavaScript to work properly. Radiology 2000;216:781-787. Furthermore FlexSegments and Cordis Nesting technology ensure pre-deployed flexibility, a minimum foreshortening and an excellent contourability*. Safety and The safety and effectiveness of the affected balloon expandable stent and CONTROL Self-Expanding Nitinol Stent, One piece laser cut stainless steel slotted tube (no welds), Laser cut slotted tube for device integrity (no welds), S shaped FlexSegments for minimal foreshortening, excellent conformability*, pre-deployed flexibility and optimal scaffolding in a bend, Lengths of delivery system: 80 and 135 cm, Metal introducer tube included in the package, N shaped FlexSegments for minimal foreshortening, excellent conformability*, pre-deployed flexibility and optimal scaffolding in a bend. MRI Safety Coronary Stents Coronary Stents Date of coronary stent placement and device manufacturer should be documented prior to MRI. We embrace a diverse, empowered culture where teammates are inspired to serve customers, patients and shareholders while fulfilling their own career aspirations. The device brand name is the Cordis PRECISE Nitinol Stent System. We impact millions of lives, in more than 60 countries around the world. By adhering to these admittedly conservative MRI conditions, patients with coronary artery stents can benefit from the diagnostic imaging information provided by one of the most important noninvasive imaging modalities. Leave nothing behind. 1.1. Stents: Evaluation of MRI safety. Radiology 2004;232:635-652. The goal of this webpage is to succinctly present the latest MRI safety guidelines developed by the MR Safety Committee Biomedical Research Publishing Group, Los Angeles, CA, 2020. Interventional. Version or Model: PC0520RXC. T a bl e 3 M. a or Adverse Events In-H . This site is Exclusively Sponsored by BRACCO, Cerebrospinal Fluid (CSF) Shunt Valves and Accessories, Orthopedic Implants, Materials, and Devices, Cardiac Pacemakers, Implantable Cardioverter Defibrillators (ICDs), and Cardiac Monitors, Vascular Access Ports, Infusion Pumps*, Catheters, and Accessories. for Recall. Theyre often used after a heart attack or in patients who are seen as high risks for arterial collapse. (8) Hug J, et al. (13) Porto I, et al. Please refer to Cordis Product Catalogue for complete product information. It has an extensive size matrix allowing for the treatment of a wide range of lesions. Cookie List The SSED for P030047 is available on the CDRH website and is incorporated by reference here. P030047, submitted by Cordis Corporation (Cordis) for the PRECISE Nitinol Stent System, was approved on September 22, 2006 for the same use proposed by Silk Road Medical, Inc. Catalog Number: PC0730RXC. Long-term clinical effects of magnetic resonance imaging in patients with coronary artery stent implantation. Field Safety Notice Overview: Cordis has initiated a labeling correction for S.M.A.R.T. Magnetic resonance imaging safety: Implications for cardiovascular patients. Guidelines for the Management of Patients with Coronary Artery Stents Referred for MRI Examinations*, Frank G. Shellock, Ph.D., FACR, FISMRM, FACC Adjunct Clinical Professor of Radiology and Medicine Keck School of Medicine, University of Southern California, Director of MRI Safety USC Stevens Neuroimagingand Informatics Institute University of Southern California. J Magn Reson Imaging. The Genesis family is designed according to the PALMAZ Stent heritage with one piece laser cut stainless steel slotted tube (no welds) and a closed-cell design. (3) Shellock FG. 8600 Rockville Pike Cordis adds the next generation of high-performance workhorse PTA balloons with the SABER .035 PTA Dilatation Catheter. PALMAZ Large Stents can be expanded between 8 and and 12 mm and the XL can be expanded between 14 and 25 mm. Cause 2. This helps prevent the blood vessel from re-closing. MRI labeling information for implants and devices: Explanation of terminology. Rev Esp Cardiol 2006;59:1261-7. Field Safety Notice Overview: Cordis has initiated a labeling correction for S.M.A.R.T. Conditional 5 More. The number of coronary stents may be over half a million world-wide. (1) Patients with all commercially available coronary artery stents (including drug-eluting and non-drug eluting or bare metal versions) can be scanned at 1.5-Tesla/64-MHz or 3-T/128-MHz, regardless of the value of the spatial gradient magnetic field. (15) Shellock FG. Guidelines. 1.5. The PALMAZ GENESIS Stent Family offers a complete range of lengths and diameters in combination with pre-mounted and stent-alone configurations. Commercial Distribution Status: In Commercial Distribution. This device can be safely used in patients undergoing MRI scans using 3 Tesla (3T) machines. Cookie Consent, RAIN Sheath Transradial Hydrophilic Thin-walled Introducer, INFINITI and SUPER TORQUE Plus Catheters Universal Shapes, IKAZUCHI ZERO Semi-Compliant PTCA Balloon, STABILIZER Balance Performance Steerable Guidewire, STABILIZER Marker Wire Steerable Guidewire, S.M.A.R.T. Cordis Endovascular Medical Info Line. The Genesis family is designed according to the PALMAZ GENESIS Stent heritage with one piece laser cut stainless steel slotted tube (no welds) and a closed-cell design. 26-27, 2005. 2009 Mar;20(2):138-42. doi: 10.1097/MCA.0b013e328322cd48. Epub 2009 Sep 26. They inspire us each and every day with their commitment to continuously move the needle. Biomedical implants and devices: Assessment of magnetic field interactions with a 3.0-Tesla MR system. Brand Name: PALMAZ GENESIS Transhepatic Biliary Stent on OPTA PRO .035" Delivery System Version or Model: PG3980BPS Commercial Distribution Status: In Commercial Distribution Catalog Number: PG3980BPS Company Name: CORDIS CORPORATION Primary DI Number: 20705032040119 Issuing Agency: GS1 Commercial Distribution End Date: Device Count: 1 The PALMAZ GENESIS Peripheral Stent family is designed according to the PALMAZ Stent heritage with one piece laser cut stainless steel slotted tube (no welds) and a closed-cell design. Terms and Conditions The PALMAZ GENESIS Peripheral Stent family is designed according to the PALMAZ Stent heritage with one piece laser cut stainless steel slotted tube (no welds) and a closed-cell design. Privacy Statement 2006 Jun;54:469-80. Clinical outcomes after sirolimus-eluting, paclitaxel-eluting, and bare metal stents (from the first phase of the prospective multicenter German DES.DE Registry). Results from the prospective multicenter German Cypher Registry]. Safety Topic / Subject . Select a Region Kaya MG, Okyay K, Yazici H, Sen N, Tavil Y, Turkoglu S, Timurkaynak T, Ozdemir M, Cemri M, Yalcin R, Cengel A. Coron Artery Dis. (20) Spuentrup E, et al. Specifications. Brand Name: Cordis PRECISE PRO Rx Nitinol Stent System. Intrauterine Contraceptive Devices (IUDs) and Other Contraceptive Devices More. Stent Securement Technology for excellent stent retention FlexSegments for flexibility, deliverability and minimal foreshortening Cordis PaLMaz 1989-1990 Cordis PaLMaz-Schatz 1991-1992 Cordis PaLMaz Corinthian 1998-1999 Cordis PaLMaz Corinthian IQ 1999-2000 Cordis PaLMaz Genesis 2001-2002 L605 (Co/Cr) MP35N (Co/Cr) 316L (SS) Lengths of delivery system: 80 and 135 cm Interventionalists and their teams now have 60 years of Cordis knowledge in their hands and at their fingertips. (16) Shellock FG. For country-specific contact details, please see this page. For more information, please contact your local Cordis representative. Would you like email updates of new search results? Is there a clear connection to practice and theory in your specific nursing specialty area? Braun Medical, www.bbraun.com, Dana Diabecare IISG Insulin PumpSooil, www.sooilusa.com, DC GDC 10-Soft SR Platinum alloy coil Boston Scientific Corporation and Stryker Neurovascular, www.stryker.com, De La CruzFluoroplastic, Platinum, PistonOtologic ImplantMedtronic Xomed, Jacksonville, T, Deck Scraper45*300-mmNewmatic Medical, www.newmaticmedical.com, Deck ScraperS-11GAmpco Safety ToolsGarland, TX, Delta Shunt AssemblyMedtronic NeurosurgeryGoleta, CA, Delta Tapered PEEK Interference ScrewArthrex, www.Arthrex.com, Delta Total ShoulderStainless SteelDePuy OrthopaedicsWarsaw, I, Delta TRSType DDDModel 0937PacemakerCardiac Pacemakers, Inc.St. Cordis is a worldwide leader in the development and manufacture of interventional vascular technology with a more than 50-year history of delivering pioneering products to treat millions of patients. Magnetic resonance-guided coronary artery stent placement in a swine model. [Safety and current indications during "real life" use of sirolimus-eluting coronary stents in Germany. Furthermore FlexSegments and Cordis Nesting technology ensure pre-deployed flexibility, a minimum foreshortening and an excellent contourability*. Device Identifier (DI) Information. MYNX CONTROL Vascular Closure Devices integrate dual-mode active sealing and resorbability with a next-generation delivery system to maximize predictability, safety, and ease of use. Braun, www.bbraunusa.com, Cytoscan NeedleB. 53, Issue 2, pp. Paul, M, Deltec Micro 3100Large Volume Infusion PumpSmiths MedicalSt. Issuing Agency: GS1. Version or Model: PC0730RXC. PALMAZ GENESIS on OPTA PRO (Large) The following guidelines apply to using MRI in patients with coronary artery stents (including patients with two or more stents or two or more overlapping stents): (1) Patients with all commercially available coronary artery stents (including drug-eluting and non-drug eluting or bare metal versions) can be scanned at 1.5-Tesla/64-MHz or 3-T/128-MHz, regardless of the value of the spatial gradient magnetic field. If you are located in Brasil, Colombia, or Mexico, please direct your order or question directly to your countrys contact. Radiology 2009;253:26-30. Cristallo Ideale Carotis Self-Expanding Stent Cylindrical version Nitinol Invatec Technology Center GmbH Thurgau, Switzerland. All items listed are on inventory. In most cases this fear is unfounded, though its still really important for people who have these devices to inform their care providers before undergoing this or any related procedure. Safety policies and procedures are evaluated on a monthly basis by the MRI Safety Committee, and updated online for reference. DELTAFILL Microcoil, Embolization Coil. Select a Region J Am Coll Cardiol 2003;42:1295-8. All current stents are MRI safe and MRI can be done anytime. Importance of Consultation Many people with coronary artery stents also have other implanted devices that include coils, filters and wires. Furthermore, FlexSegments and Cordis NESTING Technology ensure predeployed flexibility, a minimum amount of foreshortening, and excellent conformability*. The surgeon who performed the surgery should have more information about what devices were implanted and whether an MRI is safe, and MRI technicians who have a patients complete medical file can usually make better judgments, too. Patients usually have to spend time lying very still in an MRI machine, which is a contained space where controlled magnetic waves penetrate and bounce. PALMAZ Large can be expanded between 8 and and 12 mm and the XL can be expanded between 14 and 25 mm. Unfortunately, the standard policy that MRI labeling information is required before allowing the use of MRI in patients with coronary artery stents limits access to this important diagnostic imaging modality for those patients for which labeling is unavailable. The Cordis PRECISE Nitinol Stent System devices are designed to deliver a flexible, self-expanding endoluminal stent to the carotid vasculature via over-the-wire (OTW) 5.5F or 6F sheathed delivery systems. Accessibility A Cardinal Health company Open the catalog to page 1 Laser cut slotted tube for device integrity (no welds) (4) Levine GN, et al. Crossflex Stent 316L SS coil, stent, filter Cordis Miami . They have an optimal scaffolding in a bend, smooth transition from stent to balloon and an excellent stent retention. Coils, Filters, Stents, and Grafts More. As a result, it may contain information about products not available in your country. When everyone is on the same page when it comes to medical history, precautions can be taken to ensure that everything goes smoothly. and PRECISE stents due to incorrect MRI information on the Instructions for use (IFU). Coron Artery Dis 2009;20:138-42. Partial and Total Prosthesis. The PALMAZ GENESIS Peripheral Stent family offers a broad range of lengths and diameters in combination with pre-mounted and stent-alone configurations. If you are located in Australia, China, India, Japan or Korea, please direct your order or question directly to your countrys contact. The stent is cut from a solid nitinol tube into a fine mesh ( Z configuration) design. The CODMAN ENTERPRISE 2 vascular reconstruction device and positioning system is indicated for use with embolisation devices in the treatment of intracranial aneurysms. The PALMAZ GENESIS Stent Family is designed according to the PALMAZ Stent heritage with one piece laser cut stainless steel slotted tube (no welds) and a closed-cell design. Magnetic resonance compatibility research for coronary metal stents. Select a Region Cordis US As a global leader in breakthrough cardiovascular and endovascular solutions, we are the people behind the people who keep saving lives. Notably, the previous belief that it may be necessary to wait six weeks or longer after implantation of certain coronary artery stents to allow for endothelialization or other mechanism to prevent migration has been refuted because there are no known coronary artery stents made from ferromagnetic metallic materials (4-24). Hellenic J Cardiol 2019;60:38-39. and transmitted securely. Certain implants and internal medical devices can cause problems during an MRI, particularly those that are made of metal; metal can cause the magnetic and radio waves to change frequency, and these sorts of devices can also be themselves impacted and might become less effective. Closed-cell design Long-term clinical effects of magnetic resonance imaging in patients with coronary artery stent implantation. Please refer to the Instructions for Use for complete information, including indications, precautions, warnings, and potential adverse events. The surgeon who performed the surgery should have more information about what devices were implanted and whether an MRI is safe, and MRI technicians who have a patient's complete medical file can usually make better judgments, too. Clinical safety of magnetic resonance imaging early after coronary artery stent placement. Furthermore FlexSegments and Cordis Nesting technology ensure predeployed flexibility, a minimum foreshortening and an excellent contourability*. Peripheral artery stent, bare-metal A non-bioabsorbable tubular device intended to be implanted in a peripheral artery (excludes aorta, carotid, coronary, and intracranial arteries) to indefinitely maintain patency and improve luminal diameter in patients with atherosclerotic disease, or following the recanalization of a total occlusion; it . PMC For more information, please contact your local Cordis representative. One of the biggest concerns people have when undergoing MRIs is that the magnetic force of the scans will somehow knock the stents out of place. Cordis Product Catalogue Diagnostic and interventional Products. ParaMount Mini Biliary Stent. If you are a French HCP please contact your local representative. Its often the case that the care team providing the MRI isnt the same as the one that installed the stent, so they might not be aware that it is present. Metal introducer tube included in the package Silk Road Medical (SRM) has entered into a license and This may result in restricted access to MRI for certain patients, particularly those with coronary artery stents for which there is unknown labeling information. We have revie This dilatation catheter offers excellent crossability and deliverability for navigation through tortuous anatomy and difficult lesions. and PRECISE stents. Coils, Filters, Stents, and Grafts More. MeSH Clipboard, Search History, and several other advanced features are temporarily unavailable. Purpose: The iStent is a medical grade titanium implant commonly implanted in the anterior chamber angle of glaucomatous eyes in order to reduce . (5) Ahmed S, Shellock FG. [Optimal platelet inhibition after coronary stent implantation. Name of Cordis PALMAZ GENESIS Transhepatic Biliary Stent on OPTA PRO .035" affected Delivery System. Coils, Filters, Stents, and Grafts More. Close with confidence. We will be listed as Kendaall Enterprise on your bank statement. As a result, it may contain information about products not available in your country. Codman Neurovascular and Depuy Synthes, www.depuysynthes.com. Cordis has initiated a labeling correction for S.M.A.R.T. Before Characteristics. and PRECISE stents due to incorrect MRI information on the IFU. Expert Rev Med Devices 2021;18:83-90. By following the pertinent MRI labeling information (i.e., presented in the Instructions for Use, Patient Identification Card, etc. (14) Schenk CD, Gebker R, Berger A, et al. Panalok Absorbable AnchorNonmetallicDepuywww.Depuy.com, Panalok Anchorclear PLA polymer anchorMitek ProductsNorwood, MA, Panalok Loop AnchorNonmetallicDepuywww.Depuy.com, Panalok RC Loop AnchorNonmetallicDepuywww.Depuy.com, Panalok RC QA+DS Suture OrthocordNonmetallicDepuywww.Depuy.com, Panalok RC QuickAnchor PlusNonmetallicDepuywww.Depuy.com, Panje Voice ButtonHood Laboratories, www.hoodlabs.com, Papoos Infant Spinal Immobilization DeviceOssur, www.ossur.com, Paragard Intrauterine Copper Contraceptive Cooper Surgical, ParaMount Mini Biliary StentCovidien and ev3 Inc., www.ev3.net, Partial and Total Prosthesis Device Family, Partial and Total Prosthesis; Family Product Number(s), 1XX, 190-XXX; Device Material(s), HA, hydroxyapatiteGrace Medical, www.gracemedical.com, Partial and Total ProsthesisDevice Family, Partial and Total Prosthesis; Family Product Number(s), 2XX, 193; Device Material(s), HA (hydroxyapatite), SiliconeGrace Medicalhttp://www.gracemedical.com/, PAS-Port ProximalAnastomosis System ImplantCardica and Dextera Surgical, Inc., www.dexterasurgical.com, PAS-Port Shaped ImplantDextera Surgical, www.dexterasurgical.com, Passager Stent (tantalum)10 mm x 30 mmcoil, stent, filterMeadox SurgimedOakland, NJ, Passager Stent (tantalum)4 mm x 30 mmcoil, stent, filterMeadox SurgimedOakland, NJ, Patellofemoral joint (PFJ) Reconstruction SystemIBalance PFJ, Entire Family, All SizesArthrex, Inc., www.arthrex.com, Patient ScoopModel 65 EXLFerno-Washington, Inc.Wilmington, OH, Patriot Extrication CollarOssur, www.ossur.com, pBEAST Peripheral Balloon Expandable Covered StentW. 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