Distributed only in the countries of Finland, France, Germany, Great Britain, Italy, Norway, Spain, Sweden, and Switzerland.
Description du dispositif
Lotus TAVR 23mm, || Transcatheter Aortic Valve Prosthesis Premounted on Delivery System; || Sterile || Material number H749LTV230, Catalog Number LTV23; || Product Usage: The Lotus Valve System is intended to improve aortic valve function for symptomatic subjects with severe calcific aortic stenosis (aortic valve area [AVA] of <1.0 cm2 or AVA index of <0.6 em /m2) who are at extreme or high risk for standard surgical valve replacement.
Distributed only in the countries of Finland, France, Germany, Great Britain, Italy, Norway, Spain, Sweden, and Switzerland.
Description du dispositif
Lotus TAVR 25mm, || Transcatheter Aortic Valve Prosthesis Premounted on Delivery System; || Sterile || Material number H749LTV250, Catalog Number LTV25; || Product Usage: The Lotus Valve System is intended to improve aortic valve function for symptomatic subjects with severe calcific aortic stenosis (aortic valve area [AVA] of <1.0 cm2 or AVA index of <0.6 em /m2) who are at extreme or high risk for standard surgical valve replacement.
Distributed only in the countries of Finland, France, Germany, Great Britain, Italy, Norway, Spain, Sweden, and Switzerland.
Description du dispositif
Lotus TAVR 27mm, || Transcatheter Aortic Valve Prosthesis Premounted on Delivery System; || Sterile || Material number H749LTV270, Catalog Number LTV27; || Product Usage: The Lotus Valve System is intended to improve aortic valve function for symptomatic subjects with severe calcific aortic stenosis (aortic valve area [AVA] of <1.0 cm2 or AVA index of <0.6 em /m2) who are at extreme or high risk for standard surgical valve replacement.
International Only Distribution -- RUSSIA, ROMANIA, UNITED KINGDOM, GERMANY, ITALY, SPAIN, FRANCE, TURKEY, POLAND, and JAPAN.
Description du dispositif
ev3 Protege Rx Tapered Carotid Stent System, SECX-10-7-40-135, Sterile EO, Rx only. || Indicated for the treatment of patients at high risk for adverse events from carotid endarterectomy who require percutaneous carotid revascularization and meet outlined criteria.
International Only Distribution -- RUSSIA, ROMANIA, UNITED KINGDOM, GERMANY, ITALY, SPAIN, FRANCE, TURKEY, POLAND, and JAPAN.
Description du dispositif
ev3, Prot¿g¿ Rx Tapered Carotid Stent System, SEPX-8-6-40-135, Sterile EO, Rx only. || Indicated for the treatment of patients at high risk for adverse events from carotid endarterectomy who require percutaneous carotid revascularization and meet outlined criteria.
Product Codes- US product: Model No.: 1400, 1401US; International product: Model No.: 1400, 1401XX ('XX' represents country designation) Serial No.: CON000001 through CON005472
Worldwide Distribution - US Nationwide in the states of: AL, AZ, CA, CO, FL, GA, IL, IN, KY, LA, MA, MD, MI, MN, MO, NC, NY, OH, OR, PA, TX, UT, VA, WA and District of Columbia and countries of: Canada, Poland, Australia, Austria, Italy, DE, New Zealand, South Africa, France, Switzerland, Germany, Brazil, UK, Belgium, Netherlands, Israel, Malaysia, Turkey, Greece, Japan, Singapore, Poland, Lithuania, Sweden, Norway, Finland, and India.
Description du dispositif
HeartWare Ventricular Assist System (HeartWare Controller) || Product Usage: || For use as a bridge-to-cardiac transplantation in patients who are at risk of death from refractory end-stage left ventricular heart failure. The HeartWare System is designed for in-hospital and out-of-hospital settings, including transportation via fix-wing aircraft or helicopter.
Synovis VASCU-GUARD Peripheral Vascular Patch in the following sizes and product codes: 1x6cm, product code 1504026, 0.8x8cm, product code 1504028, 1x10cm, product code 1504030, and 2x9cm, product code 1504032. VASCU-GUARD is packaged between two pieces of foam within a double sterile barrier pouch system. The contents of the unopened, undamaged package are sterile. VASCU-GUARD is intended for use in peripheral vascular reconstruction including the carotid, renal, iliac, femoral, profunda, and tibial blood vessels and arteriovenous access revisions.
Distributed in the state of Michigan (USA), and the countries of United Kingdom, Australia, Poland, and Germany.
Description du dispositif
Gelseal Straight Diameter 8mm Length 15cm. || Vascular graft prosthesis is an implanted device intended to repair, replace, or bypass sections of native or artificial vessels, excluding coronary or cerebral vasculature, and to provide vascular access.
Distributed in the state of Michigan (USA), and the countries of United Kingdom, Australia, Poland, and Germany.
Description du dispositif
Gelseal Straight Diameter 8mm Length 30cm. || Vascular graft prosthesis is an implanted device intended to repair, replace, or bypass sections of native or artificial vessels, excluding coronary or cerebral vasculature, and to provide vascular access.
Worldwide Distribution - US Nationwide, Australia, Austria, Belgium, Canada, Czech Republic, Denmark, Dominican Republic, Estonia, Finland, France, Germany, Greece, Hong Kong, Ireland, Israel, Italy, Kuwait, Latvia, Lithuania, Netherlands, New Zealand, Norway, Philippines, Poland, Portugal, Qatar, Saudi Arabia, Singapore, Slovenia, Spain, Sweden, Switzerland, Turkey, United Arab Emirates and United Kingdom.
Description du dispositif
EnVeo R Loading System, Model No. LS-EnVeoR-23, LS-EnVeoR-2629, LS-EnVeoR-23-C, LS-EnVeoR-2629-C. || Cardiovascular valve delivery system for use with the Medtronic CoreValve Evolut R system.
Worldwide Distribution-US (nationwide) and the countries of Argentina, Australia, Austria, Belgium, Canada, Chile, China, Colombia, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, Germany, Great Britain, Greece, Hong Kong, Hungary, Indonesia, Iran, Ireland, Israel, Italy, Kazakhstan, Kuwait, Lebanon, Malaysia, Mexico, Netherlands, New Zealand, Oman, Panama, Philippines, Poland, Portugal, Romania, Russian Fed., Saudi Arabia, Serbia, Singapore, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, United Arab Emirates, White Russia.
Description du dispositif
Boston Scientific, WATCHMAN Left Atrial Appendage Closure Device with Delivery System, 21mm x 12F ( M635WU21060, WU21060, 24mm x 12F(M635WU24060, WU2406) , 27mm x 12F(M635WU27060, WU2706) , 30mm x 12F(M635WU30060, WU3006) , 33mm x 12F( M635WU33060, WU3306). For cardiac use.
Worldwide Distribution-US (nationwide) and the countries of Argentina, Australia, Austria, Belgium, Canada, Chile, China, Colombia, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, Germany, Great Britain, Greece, Hong Kong, Hungary, Indonesia, Iran, Ireland, Israel, Italy, Kazakhstan, Kuwait, Lebanon, Malaysia, Mexico, Netherlands, New Zealand, Oman, Panama, Philippines, Poland, Portugal, Romania, Russian Fed., Saudi Arabia, Serbia, Singapore, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, United Arab Emirates, White Russia.
Description du dispositif
Boston Scientific, WATCHMAN Access System Access Sheath with Dilator, 14F Single curve( M635TU10060, TU1006) , 14F Double curve (M635TU20060, TU2006) , & 14F Anterior curve (M635TU40060, TU4006). For cardiac use.
Worldwide Distribution US (nationwide), Belgium, Switzerland, Germany, France, United Kingdom, India, Italy, Japan, Luxembourg, The Netherlands, Saudi Arabia, and Sweden.
Description du dispositif
Optisure Dual Coil Defibrillation Leads, Model No. LDA220, LDA220Q, LDA230Q, LDP220Q. St. Jude Medical. Designed for long term attachment to an Implantable Cardioverter Defibrillator (ICD).
Worldwide Distribution - USA (nationwide) including Puerto Rico and to Algeria, Argentina, Armenia, Australia, Austria, Bangladesh, Belarus, Belgium, Bermuda, Bolivia, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Finland, France, French Polynesia, Georgia, Germany, Greece, Guatemala, Honduras, Hong Kong, Hungary , India, Indonesia, Iran, Ireland, Israel, Italy, Japan Jordan, Kazakhstan, Kenya, Kuwait, Korea, Latvia, Luxembourg, Lebanon, Lithuania, Macedonia, Malaysia, Malta, Martinique, Mauritius , Mexico, Morocco, Netherlands, New Zealand, Norway,Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Syria, Trinidad, Tobago, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Venezuela and Vietnam.
Description du dispositif
Medtronic InSync III, model 8042, 8042B and 8042U. Implantable pulse generator pacemaker.
Bard Distaflo Vascular Bypass Graft; Product Code: DF6006SC; 8 mm x 60 cm. || Intended for bypass or reconstruction of peripheral arterial blood vessels.
Bard Distaflo Vascular Bypass Graft; Product Code: DF8006SC; 6 mm x 80 cm. || Intended for bypass or reconstruction of peripheral arterial blood vessels.
Worldwide Distribution-US (nationwide) including Puerto Rico and the countries of Argentina Luxembourg Australia Malaysia Austria Mexico Belgium Netherlands Brazil New Zealand Canada Norway Colombia Philippines Corrientes Poland Czech Republic Portugal Denmark Egypt Romania Finland Saudi Arabia France Slovenia Germany Spain Greece Sweden Hong Kong Switzerland Hungary Thailand Indonesia Turkey Israel United Arab Emirates Italy United Kingdom Kuwait and Vietnam.
Description du dispositif
MitraClip Clip Delivery System, product number MSK0101. The MitraClip System || contains the Clip Delivery System, product number CDS0201, GTIN 08717648195914 and the Steerable Guide Catheter, product number SGC0101, GTIN 08717648195921. || The MitraClip Clip Delivery System (CDS) consists of three major components: 1) the Delivery Catheter 2) the Steerable Sleeve, and 3) the MitraClip device. The implantable MitraClip device is located at the distal end of the CDS. The CDS is used to advance and manipulate the implantable MitraClip device for proper positioning and placement on the mitral valve leaflets. The Delivery Catheter, which is part of the CDS, is designed to deliver and deploy the MitraClip. The Delivery Catheter extends through the thru-lumen of the Steerable Sleeve.
Worldwide Distribution-US (nationwide) including DC and PR, and the states of MN, TX, PA, OH, IL, OR, CA, SC, NC, AK, NY, MD, GA, NJ, AZ, KY, OH, WI, AL, AR, MO, FL, MA, MT, TN, LA, CT, NE, WV, VA, NV, ME, UT, CO, WY, AR, DE, NM, IN, MN, MS, NH, IA, MI, WA, VA, KS, HI, RI, SD, VT, and the countries of Hong Kong, Malaysia, Canada, Chile.
Description du dispositif
Denali Filter-Jugular/Subclavian Delivery System || Product Code: DL900J/DL950J; || Indicated for use in the prevention of recurrent pulmonary embolism via placement in the vena cava.
Worldwide Distribution-US (nationwide) including DC and PR, and the states of MN, TX, PA, OH, IL, OR, CA, SC, NC, AK, NY, MD, GA, NJ, AZ, KY, OH, WI, AL, AR, MO, FL, MA, MT, TN, LA, CT, NE, WV, VA, NV, ME, UT, CO, WY, AR, DE, NM, IN, MN, MS, NH, IA, MI, WA, VA, KS, HI, RI, SD, VT, and the countries of Hong Kong, Malaysia, Canada, Chile.
Description du dispositif
Denali Filter-Femoral Delivery System || Product Code: DL900F/DL950F; || Indicated for use in the prevention of recurrent pulmonary embolism via placement in the vena cava.
US Nationwide distribution in the states of AL, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KY, LA, MA, MD, MI, MO, MS, NC, NE, NJ, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and Washington D.C.
Description du dispositif
HeartWare Ventricular Assist System: HeartWare Battery, Lithium Ion, 14.8 V, Rx only. Catalog 1650 (US) and 1650, 1650-DE and A00035 (OUS) || Product Usage: || Used as a bridge-to-cardiac transplantation in patients who are at risk of death from refractory end-stage left ventricular heart failure. The HeartWare Ventricular Assist System is designed for in-hospital and out-of-hospital settings, including transportation via fixed-wing aircraft or helicopter.
AUSTRIA, AUSTRALIA, BELGIUM, SWITZERLAND, GERMANY, DENMARK, FRANCE, GREAT BRITAIN, HUNGARY, JAPAN, NETHERLANDS, NEW ZEALAND, POLAND, PORTUGAL, SWEDEN.
Description du dispositif
Medtronic CareLink" Monitor (2490C) and Medtronic CareLink Express" Monitor (2020B) || Product Usage: || The 2490C CareLink Home Monitors and 2020B CareLink Express Monitors are remote monitoring systems that interrogate implanted devices and transmit the data to Medtronic s CareLink Network for viewing by the physician. The data is transmitted either through an analog telephone line, a cellular connection or an internet connection.
Worldwide Distribution - US Nationwide in the states of CT, NJ, SC, FL, GA and countries of: Finland, France, Germany, Great Britain, Greece, Israel, Italy, Japan, Kuwait, Lebanon, Netherlands, Northern Ireland, Poland, Romania, Slovakia, Spain, Tunis, United Arab Emirates, and Vietnam.
Description du dispositif
Ellipse ICD (Implantable Cardioverter Defibrillator) Model CD2411-36Q, CD2411-36C, CD1411-36Q, CD1411-36C || Product Usage: || Ellipse ICD devices are intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias.