Claria and Wide CRT-D MRI, serial RPB603896S, RPB603895S
Description du dispositif
The CLARIA MRI system is indicated for use in patients with a high risk of sudden death due to ventricular tachyarrhythmias and who suffer from heart failure with ventricular dyssynchrony. The device is designed to provide atrial, ventricular or both atrial pacing, cardioversion and defibrillation for the automatic treatment of atrial, ventricular tachyarrhythmias, or both, which may endanger the patient's life.
The ENDURANT endoprosthesis system is designed to treat infrarenal abdominal aortic or aortic iliac aorticilies using an endovascular technique. Once placed within the ureurysm, the enduran stent offers an alternative permanent conduit for blood flow within the vascular system of the patient, since it excludes the aneurysmal sac from blood flow and pressure.
Euphora and Solarice, lots 212553130 to 213283557.
Description du dispositif
The dilatation balloon catheter is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis in order to improve myocardial perfusion. The dilatation balloon catheter is also indicated for post-deployment expansion of expandable balloon stents.
The COREVALVE system from Medtronic is intended for the replacement of a poor aortic heart valve trans-luminal porentrega. Its purpose is to restore normal function to the deficient aortic valve of the patient. The MEDtronic COREVALVE system is indicated for patients with symptomatic native aortic valve stenosis or a failure of the surgical bio-prosthesis of the valve (defined as deficient, stenosed, or both) that need replacement. of valve presenting vessels of ataxillary / subclavian or femoral access with diameters greater than oigual to 6 mm or ascending aortic access point (direct aortic) greater than or equal to 60mm from the basal plane.
11001G, 13001, 15004, 25009, 25010, 61000 and 62000
Description du dispositif
They are used during cardiopulmonary bypass surgeries to alternately administer cardioplegic solutions and ventilate the heart. Simultaneous venous drainage through the right atrium and the inferior vena cava.
The O-ARM® system is a multidimensional surgical imaging platform optimized for use in spine surgeries and surgeries related to orthopedic trauma. It brings intraoperative image projection to a new level with superior quality of the image and visual field in 2 and 3 dimensions, allowing the surgeon to confirm the accuracy of advanced surgical procedures before the patient leaves the operating room. Integrating seamlessly with navigation, the O-ARM ® SYSTEM reduces x-ray exposure, increasing safety for both medical personnel and patients.
The O-ARM system is a multidimensional surgical imaging platform optimized for use in dorsal spinal surgeries and surgeries related to orthopedic trauma. Trauprojection of intraoperative image to a new level with superior quality of the image and visual field in 2 and 3 dimensions, allowing the surgeon to confirm the accuracy of advanced surgical procedures before the patient leaves the operating room. Integrating without problems with navigation, the O-ARM SYSTEM reduces x-ray exposure, increasing safety for both medical personnel and patients.
The O-ARM system is a multidimensional surgical imaging platform optimized for use in dorsal spinal surgeries and surgeries related to orthopedic trauma. Projection of intraoperative image to a new level with superior quality of the image and visual field in 2 and 3 dimensions, allowing the surgeon to confirm the accuracy of advanced surgical procedures before the patient leaves the operating room. Integrating no problems with navigation, the O-ARM SYSTEM reduces exposure to lightning rods, increasing safety for both medical personnel and patients.
The MEDTRONIC computer-assisted surgery system and its associated applications were conceived to help localize anatomical structures and plan surgical trajectories in open and percutaneous interventions. Its use is indicated for any clinical disorder for which it is considered appropriate to employ stereotactic surgery and where a reference to a rigid anatomical structure can be established in relation to diagnostic images of laanatomy.
The MEDTRONIC computer-assisted surgery system and its associated applications were designed to help locate anatomical structures and plan surgical trajectories in open and percutaneous interventions. Its use is indicated for any clinical disorder for which it is considered appropriate to use stereotactic surgery and where it can establish a reference to a rigid anatomical structure in relation to diagnostic images of the anatomy.
It is indicated for use when the patient's therapy requires cornica medication infusion. The system is approved for use with: sterile solution of demorphine hydrochloride / morphine sulfate free of preservatives in the treatment of intractable chronic pain. Intrathecal injection debaclofen in the management of severe spasticity. Sterile solution of ziconotide free of condoms for severe chronic pain management. chronic intravascular infusion defloxuridine and methotrexate for the treatment of primary or metastatic cancer (not for use with the intrathecal catheter ascends)
ES300, ES300-R, ES310 and ES310-R, specific serial
Description du dispositif
The MIDAS REX LEGEND EHS and EHS STYLUS systems are used in neurosurgery, spine surgery, general surgery, otorhinolaryngology, maxillofacial surgery and craniofacial surgical applications.
Description: AFFINITY arterial blood filters are sterile, non-pyrogenic devices for single use and are designed to filter micro-symbols of the largest size circuit in microns specified, for periods of up to 6 hours during cardiopulmonary bypass surgery. Use: these filters are indicated for use in all cardiopulmonary bypass procedures for the removal of particles and gaseous micro piston. The filters are single-use, sterile, non-pyrogenic devices designed to filter micro-plots larger than the specified micron size from the circuit of periods of up to six hours during cardiopulmonary bypass surgery. AFFINITY351 / cb351 arterial filter (38μ, 351 / cb351 arterial blood filter (20μ arterial blood filter) AFFFITY arterial blood filters are sterile, non-pyrogenic devices for single use and are designed to filter microcircuits of the circuit greater than the specified micron size, for periods of up to 6 hours during cardiopulmonary bypass surgery AFFINITY arterial blood filters carmeda (cb351 and cb 353) are coated with an impermeable bioactive surface (heparin), which provides blood contact surfaces resistant to thrombus formation TRILLIUM AFFINITRY NT 541t: the membrane oxygenator with integrated CVR AFFINITY NT (plasma-resistant defibra oxygenator (PRF) with bioactive surface TRILLIUM is designed to be used in an extracorporeal perfusion circuit to collect venous blood and blood-pitched cardiotomy, to heat or cool the blood, and to oxygenate and eliminate the dioxide blood carbon during systemic cardiopulmonary bypass procedures for up to 6 hours.
RestoreUltra model - 97712 and RestoreSensor - 97714, used with "8870" application card and with programmer || medical "8840"
Description du dispositif
The MEDTRONIC ITREL® NEUROSTIMULATOR is part of a neurostimulation system for therapy against pain. It is indicated for spinal cord stimulation (SCS) therapy against chronic intractable pain, trunk and / or extremities, peripheral vascular disease, or intractable angina pectoris. It is also indicated for the stimulation of the peripheral nerve (PNS) as an aid in the management of chronic pain, difficult to treat the posterior trunk and / or extremities.
The REVEAL LINQ cardiac monitor from MEDTRONIC is a programmable device that continuously monitors the ECG and other physiological parameters of the patient. The device registers cardiac in response to the activation of the patient and the arrhythmias that have been detected automatically. It is indicated in the following cases: Patients with clinical syndromes osituations with greater risk of cardiac arrhythmias. Patients who experience transient symptoms that may suggest cardiac arrhythmia.
MEDTRONIC deep brain stimulation therapy is indicated for the unilateral orbital stimulation of the internal pale globe (IPG) or the sub-thalamic nucleus (STN) in the following cases: Parkinson's disease: indicated for adjuvant therapy in the reduction of some of the symptoms of advanced Parkinson's disease in patients with a response to levodopa and who do not control it adequately with medication. Trembling and dikinesias: indicated for the suppression of tremor in the upper extremities. Intended for patients diagnosed with essential tremor or tremor associated with Parkinson's disease not adequately controlled by medication and where the tremor constitutes a significant loss of functionality. Dystonia: indicated as aid for the treatment of intractable chronic primary dystonia (resistant to medication), including generalized and segmental dystonia, hemidystonia and cervical dystonia (torticollis), for people 7 years of age or older. Epilepsy: indicated as therapy adjuvant to reduce the frequency of seizures in adult patients diagnosed with epilepsy characterized by initial partial seizures with or without secondary generalization resistant to antiepileptic drugs. Obsessive-compulsive disorder: indicated for the bilateral stimulation of the internal capsule of the anterior limbus (AIC) as a complement to medication and as an alternative for the treatment of chronic obsessive-compulsive disorder resistant to treatment with serotonin inhibitors.
MEDTRONIC deep brain stimulation therapy is indicated for the unilateral orbital stimulation of the internal pale globe (IPG) or the sub-thalamic nucleus (STN) in the following cases: depharkinson disease: indicated for adjuvant therapy in the reduction of some of the symptoms of advanced Parkinson's disease in patients with a response to levodopa and who do not control it adequately with medication. Trembling and dikinesias: indicated for the suppression of tremor in the upper extremities. Intended for patients diagnosed with essential tremor or tremor associated with Parkinson's disease not adequately controlled by medication and where the tremor constitutes a significant loss of functionality. Dystonia: indicated as aid for the treatment of intractable chronic primary dystonia (resistant to medication), including generalized and segmental dystonia, hemidystonia and cervical dystonia (torticollis), for people 7 years of age or older. Epilepsy: indicated as therapy adjuvant to reduce the frequency of seizures in adult patients diagnosed with epilepsy characterized by initial partial seizures with or without secondary generalization resistant to antiepileptic drugs. Obsessive-compulsive disorder: indicated for the bilateral stimulation of the internal capsule of the anterior limbus (AIC) as a complement to medication and as an alternative for the treatment of chronic obsessive-compulsive disorder resistant to treatment with serotonin inhibitors.
extensions for deep brain stimulation, model 7483 and 37086, all series.
Description du dispositif
MEDTRONIC deep brain stimulation therapy is indicated for the unilateral orbital stimulation of the internal pale globe (IPG) or the sub-thalamic nucleus (STN) in the following cases: depharkinson disease: indicated for adjuvant therapy in the reduction of some of the symptoms of advanced Parkinson's disease in patients with a response to levodopa and who do not control it adequately with medication. Trembling and dikinesias: indicated for the suppression of tremor in the upper extremities. Intended for patients diagnosed with essential tremor or tremor associated with Parkinson's disease not adequately controlled by medication and where the tremor constitutes a significant loss of functionality. Dystonia: indicated as aid for the treatment of intractable chronic primary dystonia (resistant to medication), including generalized and segmental dystonia, hemidystonia and cervical dystonia (torticollis), for people 7 years of age or older. Epilepsy: indicated as therapy adjuvant to reduce the frequency of seizures in adult patients diagnosed with epilepsy characterized by initial partial seizures with or without secondary generalization resistant to antiepileptic drugs. Obsessive-compulsive disorder: indicated for the bilateral stimulation of the internal capsule of the anterior limbus (AIC) as a complement to medication and as an alternative for the treatment of chronic obsessive-compulsive disorder resistant to treatment with serotonin inhibitors.
MEDTRONIC deep brain stimulation therapy is indicated for the unilateral or bilateral stimulation of the internal pale balloon (IPG) or the sub-thalamic nucleus (STN) in the following cases: Parkinson's disease: indicated for adjuvant therapy in the reduction of some of the symptoms of advanced Parkinson's disease in patients with a response to levodopa and who do not control it adequately with medication. Essential tremor and dikinesias: indicated for the suppression of tremor in the upper extremities. Intended for patients diagnosed with essential contamblor or tremor associated with Parkinson's disease not adequately controlled by medication and where tremor is a significant loss of functionality. Dystonia: indicated as an aid for the treatment of intractable primary chromosome (resistant to medication) dystonia, including generalized and segmental dystonia, hemidystonia, and cervical dystonia (torticollis), for persons 7 years of age or older. Epilepsy: indicated as adjuvant therapy to reduce the frequency of convulsions in adult patients diagnosed with epilepsy characterized by initial partial seizures with or secondary syngeneization resistant to anti-epileptic drugs. Obsessive-compulsive disorder: indicated for bilateral stimulation of the internal capsule of the anterior limbus (AIC) as complement to medication and as an alternative for the treatment of chronic compulsive obsessive-compulsive disorder resistant to treatment with serotonin inhibitors.
Hydrophilic microguide mod X-CELERATOR 0.010 "300cm, Hydrophilic microguide mod X-CELERATOR 0.014" 300cm, || MARATHON 1.5F / 2.7F microcatheter 165cm guide 0.010 "|| 25cm, ALLIGATOR recovery system 2mm 175cm || OD 0.40mm, ALLIGATOR recovery system 3mm || 175cm OD 0.40mm, ALLIGATOR RETRIEVALDEVICE. 4mm, || all batches with Expiration date between June 2017 and || August 2019.