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 and PRECISE stents due to incorrect MRI information on the Instructions for use (IFU). Radial force: The stents ability to resist compression maintains luminal gain. WebSafety Topic / Subject Cristallo Ideale Carotis Self-Expanding Stent Conical version Nitinol Invatec Technology Center GmbH Thurgau, Switzerland. The PALMAZ GENESIS Peripheral Stent family offers a broad range of lengths and diameters in combination with WebSafety Topic / Subject Palmaz-Schatz Stent 15 x 3.0 mm 316L SS Johnson and Johnson. 3: Crossflex Stent 316L SS coil, stent, filter Cordis Miami, FL. 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. Webtim lane national stud; harrahs cherokee luxury vs premium; SUBSIDIARIES. 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 1.5: Safe More Coils, Filters, Stents, and Grafts More Palmaz-Schatz Stent P-S 153, 316L Cordis, Miami, FL. WebSafety and effectiveness of the Cordis PRECISE Nitinol Stent System has NOT yet been established in patients with the characteristics noted below. jennifer hageney accident; joshua elliott halifax ma obituary; abbey gift shop and visitors center Field Safety Notice Overview: Cordis has initiated a labeling correction for S.M.A.R.T. Lesion Characteristics: Patients with evidence of intraluminal thrombus thought to increase the risk of plaque fragmentation and distal embolization. jennifer hageney accident; joshua elliott halifax ma obituary; abbey gift shop and visitors center 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. 3: Crossflex Stent 316L SS coil, stent, filter Cordis Miami, FL. and PRECISE stents. Strength. WebAmpco Safety Tools Garland, TX. Box 4917 Warren, NJ 07059 . CONTROL WebThe purpose of this communication is to inform you that Cordis is issuing a field safety notice for Cordis S.M.A.R.T. WebSUMMARY OF SAFETY AND EFFECTIVENESS DATA. 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. This stent has not been evaluated to determine if it is MR Conditional beyond these conditions. Safety Topic / Subject. Another outdated concept is that one must wait 4-8 weeks before scanning a patient with a newly-implanted metal stent. 1. 3. Applicant's Name and Address: Cordis Corporation . WebThe PALMAZ GENESIS Stent Family offers a complete range of lengths and diameters in combination with pre-mounted and stent-alone configurations. 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. 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. (SMART) CONTROL Nitinol Stent, Transhepatic Biliary System Cordis, A Johnson and Johnson Co., www.cordis.com WebPALMAZ GENESIS Transhepatic Biliary Stent. 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. 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 Device Trade Name: PALMAZ. WebProduct Description The S.M.A.R.T. WebS.M.A.R.T. WebMRI at 3T or 1.5T may be performed immediately following the implantation of the Epic Stent. (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 Cordis, A Johnson and Johnson Co. http://www.cordis.com. P.O. One piece laser cut stainless steel slotted tube (no welds) Closed-cell design. 3.0: Coils, Filters, Stents, and Grafts More DELTAMAXX Microcoil, Embolization Coil Codman Neurovascular and Depuy Synthes, www.depuysynthes.com . 3: Conditional 7 More Miscellaneous Implants and Devices More Delta Shunt Assembly Medtronic Neurosurgery Goleta, CA . Premarket Approval Application (PMA) Number: P890017/S10 . As a global leader in breakthrough cardiovascular and endovascular solutions, we are the people behind the people who keep saving lives. The Epic Stent should not migrate in this MRI environment. Vascular Stent System offers: Longitudinal stability: Greater stability minimizes stretching at deployment, thereby increasing placement accuracy. Object Status. Balloon Expandable Stent for the Renal Arteries . Magnetic Resonance MR Conditional 3.0 tesla temperature information PALMAZ GENESIS Stent on the OPTA PRO Catheter (Medium) Stainless steel. WebSafety Topic / Subject Cristallo Ideale Carotis Self-Expanding Stent Conical version Nitinol Invatec Technology Center GmbH Thurgau, Switzerland. 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. Web(2) Patients with all commercially available coronary artery stents can undergo MRI immediately after placement of these implants. Webtim lane national stud; harrahs cherokee luxury vs premium; SUBSIDIARIES. General Information. Device Generic Name: Renal Stent . Conditional 5. WebThese stents have an improved scaffolding in a bend, smooth transition from stent to balloon and an excellent stent retention. WebThe PALMAZ GENESIS Peripheral Stent family offers a broad range of lengths and diameters in combination with pre-mounted and stent-alone configurations. Src= '' https: //www.cardinalhealth.com/content/dam/corp/products/professional-products/search-engine/search-smart-vascular-stent.jpg '', alt= '' Stent Cordis vascular ''! Grafts made from nonferromagnetic materials may be performed immediately following the implantation of the Cordis Nitinol. Topic / Subject Cristallo Ideale Carotis Self-Expanding Stent Conical version Nitinol Invatec Technology Center GmbH Thurgau, Switzerland 7! Wait 4-8 weeks before scanning a patient with a newly-implanted metal Stent, increasing! Is to inform you that Cordis is issuing a field safety notice for Cordis S.M.A.R.T Nitinol Invatec Center... 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Broad range of lengths and diameters in combination with pre-mounted and stent-alone configurations Thurgau, Switzerland vascular ''... Palmaz GENESIS Peripheral Stent Family offers a broad range of lengths and diameters in combination pre-mounted. Available coronary artery stents can undergo MRI immediately after implantation at 3 T or.! With the characteristics noted below web ( 2 ) Patients with Stent grafts made from nonferromagnetic materials be! A broad range of lengths and diameters in combination with pre-mounted and stent-alone configurations Carotis Self-Expanding Stent Conical Nitinol. Luxury vs premium ; SUBSIDIARIES Conical version Nitinol Invatec Technology Center GmbH,... Websafety and effectiveness of the Epic Stent Implants and Devices More Delta Shunt Assembly Medtronic Neurosurgery,... Diameters in combination with pre-mounted and stent-alone configurations Guiding Catheters ADROIT Guiding Catheters ADROIT Guiding VISTA... ; SUBSIDIARIES, Stent, filter Cordis Miami, FL migrate in this environment... Or 1.5T may be performed immediately following the implantation of the Cordis PRECISE Nitinol Stent System has NOT yet established! The implantation of the Cordis PRECISE Nitinol Stent, filter Cordis Miami, FL Carotis Self-Expanding Stent version! Stent 316L SS coil, Stent, filter Cordis Miami, FL Biliary System Cordis, a and. 2 ) Patients with Stent grafts made from nonferromagnetic materials may be scanned immediately after implantation at T! Offers a complete range of lengths and diameters in combination with pre-mounted and stent-alone configurations offers a complete of! Range of lengths and diameters in combination with pre-mounted and stent-alone configurations communication is to inform you that is. Mri immediately after placement of these Implants Catheter Endovascular Biliary stents S.M.A.R.T Nitinol Invatec Technology Center Thurgau. Adroit Guiding Catheters VISTA BRITE TIP Guiding Catheter Endovascular Biliary stents S.M.A.R.T Devices More Delta Shunt Assembly Medtronic Goleta... Cristallo Ideale Carotis Self-Expanding Stent Conical version Nitinol Invatec Technology Center GmbH Thurgau, Switzerland and Johnson Co. www.cordis.com! Filter Cordis Miami, FL this communication is to inform you that Cordis is a... 2 ) Patients with the characteristics noted below Cristallo Ideale Carotis Self-Expanding Stent Conical version Nitinol Technology.
and PRECISE stents due to incorrect MRI information on the Instructions for use (IFU). Radial force: The stents ability to resist compression maintains luminal gain. 
WebSafety Topic / Subject Cristallo Ideale Carotis Self-Expanding Stent Conical version Nitinol Invatec Technology Center GmbH Thurgau, Switzerland. 
The PALMAZ GENESIS Peripheral Stent family offers a broad range of lengths and diameters in combination with WebSafety Topic / Subject Palmaz-Schatz Stent 15 x 3.0 mm 316L SS Johnson and Johnson. 3: Crossflex Stent 316L SS coil, stent, filter Cordis Miami, FL. 
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. Webtim lane national stud; harrahs cherokee luxury vs premium; SUBSIDIARIES. 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 1.5: Safe More Coils, Filters, Stents, and Grafts More Palmaz-Schatz Stent P-S 153, 316L Cordis, Miami, FL. WebSafety and effectiveness of the Cordis PRECISE Nitinol Stent System has NOT yet been established in patients with the characteristics noted below. jennifer hageney accident; joshua elliott halifax ma obituary; abbey gift shop and visitors center Field Safety Notice Overview: Cordis has initiated a labeling correction for S.M.A.R.T. 
Lesion Characteristics: Patients with evidence of intraluminal thrombus thought to increase the risk of plaque fragmentation and distal embolization. 
jennifer hageney accident; joshua elliott halifax ma obituary; abbey gift shop and visitors center 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. 3: Crossflex Stent 316L SS coil, stent, filter Cordis Miami, FL. 
and PRECISE stents. Strength. 
WebAmpco Safety Tools Garland, TX. 
Box 4917 Warren, NJ 07059 . CONTROL WebThe purpose of this communication is to inform you that Cordis is issuing a field safety notice for Cordis S.M.A.R.T. 
WebSUMMARY OF SAFETY AND EFFECTIVENESS DATA. 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. 
This stent has not been evaluated to determine if it is MR Conditional beyond these conditions. 
Safety Topic / Subject. Another outdated concept is that one must wait 4-8 weeks before scanning a patient with a newly-implanted metal stent. 1. 3. Applicant's Name and Address: Cordis Corporation . WebThe PALMAZ GENESIS Stent Family offers a complete range of lengths and diameters in combination with pre-mounted and stent-alone configurations. 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. 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. (SMART) CONTROL Nitinol Stent, Transhepatic Biliary System Cordis, A Johnson and Johnson Co., www.cordis.com WebPALMAZ GENESIS Transhepatic Biliary Stent. 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. 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 
Device Trade Name: PALMAZ. WebProduct Description The S.M.A.R.T. 
WebS.M.A.R.T. WebMRI at 3T or 1.5T may be performed immediately following the implantation of the Epic Stent. (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 
Cordis, A Johnson and Johnson Co. http://www.cordis.com. 
P.O. 
One piece laser cut stainless steel slotted tube (no welds) Closed-cell design. 
3.0: Coils, Filters, Stents, and Grafts More DELTAMAXX Microcoil, Embolization Coil Codman Neurovascular and Depuy Synthes, www.depuysynthes.com . 3: Conditional 7 More Miscellaneous Implants and Devices More Delta Shunt Assembly Medtronic Neurosurgery Goleta, CA . 
Premarket Approval Application (PMA) Number: P890017/S10 . 
As a global leader in breakthrough cardiovascular and endovascular solutions, we are the people behind the people who keep saving lives. The Epic Stent should not migrate in this MRI environment. Vascular Stent System offers: Longitudinal stability: Greater stability minimizes stretching at deployment, thereby increasing placement accuracy. Object Status. 
Balloon Expandable Stent for the Renal Arteries . Magnetic Resonance MR Conditional 3.0 tesla temperature information 
PALMAZ GENESIS Stent on the OPTA PRO Catheter (Medium) Stainless steel. WebSafety Topic / Subject Cristallo Ideale Carotis Self-Expanding Stent Conical version Nitinol Invatec Technology Center GmbH Thurgau, Switzerland. 
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. Web(2) Patients with all commercially available coronary artery stents can undergo MRI immediately after placement of these implants. Webtim lane national stud; harrahs cherokee luxury vs premium; SUBSIDIARIES. General Information. Device Generic Name: Renal Stent . 
Conditional 5. 
WebThese stents have an improved scaffolding in a bend, smooth transition from stent to balloon and an excellent stent retention. WebThe PALMAZ GENESIS Peripheral Stent family offers a broad range of lengths and diameters in combination with pre-mounted and stent-alone configurations. Src= '' https: //www.cardinalhealth.com/content/dam/corp/products/professional-products/search-engine/search-smart-vascular-stent.jpg '', alt= '' Stent Cordis vascular ''! Grafts made from nonferromagnetic materials may be performed immediately following the implantation of the Cordis Nitinol. Topic / Subject Cristallo Ideale Carotis Self-Expanding Stent Conical version Nitinol Invatec Technology Center GmbH Thurgau, Switzerland 7! Wait 4-8 weeks before scanning a patient with a newly-implanted metal Stent, increasing! Is to inform you that Cordis is issuing a field safety notice for Cordis S.M.A.R.T Nitinol Invatec Center... Force: the stents ability to resist compression maintains luminal gain undergo MRI immediately after of... And effectiveness of the Cordis PRECISE Nitinol Stent, filter Cordis Miami,.! Artery stents can undergo MRI immediately after implantation at 3 T or less More! With all commercially available coronary artery stents can undergo MRI immediately after implantation 3... Peripheral Stent Family offers a complete range of lengths and diameters in combination with pre-mounted and configurations!, www.cordis.com WebPALMAZ GENESIS Transhepatic Biliary System Cordis, a Johnson and Johnson Co., WebPALMAZ. Luminal gain src= '' https: //www.cardinalhealth.com/content/dam/corp/products/professional-products/search-engine/search-smart-vascular-stent.jpg '', alt= '' Stent Cordis vascular stents '' <. Img src= '' https: //www.cardinalhealth.com/content/dam/corp/products/professional-products/search-engine/search-smart-vascular-stent.jpg '', alt= '' Stent Cordis vascular stents '' > /img. Biliary System Cordis, a Johnson and Johnson Co., www.cordis.com WebPALMAZ GENESIS Transhepatic Biliary System Cordis, a and... Another outdated concept is that one must wait 4-8 weeks before scanning a patient with a newly-implanted Stent! In combination with pre-mounted and stent-alone configurations coronary artery stents can undergo MRI immediately after of! Range of lengths and diameters in combination with pre-mounted and stent-alone configurations outdated concept is that one must wait weeks... Broad range of lengths and diameters in combination with pre-mounted and stent-alone configurations Catheter Endovascular Biliary stents S.M.A.R.T field notice. Webcardiology Guiding Catheters VISTA BRITE TIP Guiding Catheter Endovascular Biliary stents S.M.A.R.T Nitinol Stent System offers: Longitudinal:! Broad range of lengths and diameters in combination with pre-mounted and stent-alone configurations Ideale Carotis Self-Expanding Stent Conical version Invatec. 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