Device Generic Name: Renal Stent . 
WebA field safety notice has been issued to correct a labelling issue by Cordis for self-expanding stents under MRI, specifically for SMART and PRECISE. Brand Name: PALMAZ GENESIS Transhepatic Biliary Stent on OPTA PRO .035" Delivery System Version or Model: PG3970BPX Commercial Distribution Status: In Commercial Distribution Catalog Number: PG3970BPX Company Name: CORDIS CORPORATION Primary DI Number: 20705032040041 Issuing Agency: GS1 3: Conditional 7 More Miscellaneous Implants and Devices More Delta Shunt Assembly Medtronic Neurosurgery Goleta, CA . 1.5: Safe More Coils, Filters, Stents, and Grafts More Palmaz-Schatz Stent P-S 153, 316L Cordis, Miami, FL. The Epic Stent should not migrate in this MRI environment. Magnetic Resonance MR Conditional 3.0 tesla temperature information 
3. 
WebSummary of Safety and Probable Benefit General Information Device Generic Name: Intracranial Stent Device Trade Name: CORDIS ENTERPRISE TM Vascular Reconstruction Device and Delivery System Applicant's Name and Address: Cordis Neurovascular, Inc. 14000 NW 57th Court Miami Lakes, FL 33014 USA Humanitarian Device Exemption 
WebCardiology Guiding Catheters ADROIT Guiding Catheters VISTA BRITE TIP Guiding Catheter Endovascular Biliary Stents S.M.A.R.T. Biliary Stent S.M.A.R.T. Safety Topic / Subject. 3: Crossflex Stent 316L SS coil, stent, filter Cordis Miami, FL. Box 4917 Warren, NJ 07059 . (SMART) CONTROL Nitinol Stent, Transhepatic Biliary System Cordis, A Johnson and Johnson Co., www.cordis.com WebSafety and effectiveness of the Cordis PRECISE Nitinol Stent System has NOT yet been established in patients with the characteristics noted below. WebAmpco Safety Tools Garland, TX. Applicant's Name and Address: Cordis Corporation . and PRECISE stents due to incorrect MRI information on the Instructions for use (IFU). Object Status. The PALMAZ GENESIS Peripheral Stent family offers a broad range of lengths and diameters in combination with WebSafety Topic / Subject Cristallo Ideale Carotis Self-Expanding Stent Conical version Nitinol Invatec Technology Center GmbH Thurgau, Switzerland. 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. and PRECISE stents. jennifer hageney accident; joshua elliott halifax ma obituary; abbey gift shop and visitors center WebSafety Topic / Subject Palmaz-Schatz Stent 15 x 3.0 mm 316L SS Johnson and Johnson. WebSUMMARY OF SAFETY AND EFFECTIVENESS DATA. CONTROL WebMost aortic stent grafts that have been tested have been labeled as MR safe; the Zenith AAA endovascular graft stent has been labeled as MR unsafe. 1,3 Patients with stent grafts made from nonferromagnetic materials may be scanned immediately after implantation at 3 T or less. WebFor 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. Balloon Expandable Stent for the Renal Arteries . WebThe PALMAZ GENESIS Stent Family offers a complete range of lengths and diameters in combination with pre-mounted and stent-alone configurations. Device Trade Name: PALMAZ. Cordis Corporation is recalling their Precise PRO Rx US Carotid System because of a risk of separation of the atraumatic distal tip of the sheathed delivery system in patients. jennifer hageney accident; joshua elliott halifax ma obituary; abbey gift shop and visitors center Webtim lane national stud; harrahs cherokee luxury vs premium; SUBSIDIARIES. WebProduct Description The S.M.A.R.T. WebPALMAZ GENESIS Transhepatic Biliary Stent. WebAlthough safe to scan as long as conditions are followed, some stents like the Zenith produce a substantial susceptibility artifacts making assessment of stent patency by MRI difficult. One piece laser cut stainless steel slotted tube (no welds) Closed-cell design. Radial force: The stents ability to resist compression maintains luminal gain. P.O. PALMAZ GENESIS Stent on the OPTA PRO Catheter (Medium) Stainless steel. 1. (3) The MRI examination must be performed using the following parameters: 1.5-Tesla or 3-Tesla, only Whole body averaged specific absorption rate (SAR) of 2-W/kg (i.e., operating in the General Information. WebThe purpose of this communication is to inform you that Cordis is issuing a field safety notice for Cordis S.M.A.R.T. Lesion Characteristics: Patients with evidence of intraluminal thrombus thought to increase the risk of plaque fragmentation and distal embolization. WebSafety Topic / Subject Cristallo Ideale Carotis Self-Expanding Stent Conical version Nitinol Invatec Technology Center GmbH Thurgau, Switzerland. Cordis, A Johnson and Johnson Co. http://www.cordis.com. Web(2) Patients with all commercially available coronary artery stents can undergo MRI immediately after placement of these implants. WebMRI at 3T or 1.5T may be performed immediately following the implantation of the Epic Stent. Conditional 5. Premarket Approval Application (PMA) Number: P890017/S10 . WebS.M.A.R.T. This stent has not been evaluated to determine if it is MR Conditional beyond these conditions. Vascular Stent System offers: Longitudinal stability: Greater stability minimizes stretching at deployment, thereby increasing placement accuracy. PALMAZ GENESIS on OPTA PRO (Medium) Stainless steel One piece laser cut stainless steel slotted tube (no welds) Closed-cell design Laser cut slotted tube for device integrity (no Field Safety Notice Overview: Cordis has initiated a labeling correction for S.M.A.R.T. WebThese stents have an improved scaffolding in a bend, smooth transition from stent to balloon and an excellent stent retention. 3.0: Coils, Filters, Stents, and Grafts More DELTAMAXX Microcoil, Embolization Coil Codman Neurovascular and Depuy Synthes, www.depuysynthes.com . 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