The EpiDiscTM Perforation Patch Kitis intended for use during myringoplasty as an adjunct to aid in the healing of tympanic membrane perforations. Surgeons and cardiologists should continue to follow-up with their patients as per their usual practice and in accordance with published guidelines. The Mosaic valve reflects the asymmetry of the native porcine valve. Important Safety Information. (Care should be taken to avoid water entering the ear. Instructions for Use. The hazard alert and recall only affect the Medtronic Mosaic Porcine Aortic Bioprosthesis Model 305 (all sizes and configurations, Standard and Ultra) and its associated sizing materials. VALVE 310C31 MOSAIC MIT CINCH US Medical Device Identification Home FLEX H/A is a homogenous, nonporous composite of two well-known biomaterials: hydroxylapatite and silicone. 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, operating in the Normal Operating Mode for the MR system Maximum imaging time, 15 minutes per pulse sequence (multiple sequences per patient are allowed) VALVE 310C31 MOSAIC MIT CINCH US Medical Device Identification FDA .report PMA PMN De Novo MAUDE GUDID NDC DailyMed Drug Applications MOSAIC GUDID 00613994688996 VALVE 310C31 MOSAIC MIT CINCH US MEDTRONIC, INC. FDA.report GUDID MEDTRONIC, INC. 00613994688996 The Avalus bioprosthesis is a pericardial aortic surgical valve designed for better overall performance, improved implant experience, and a contemporary design to facilitate future valve-in-valve (ViV). There is a risk of non-sterile product and patient infection, in case any unutilized portions of product were to be re-used after first application. Cardiovascular MR Conditional, nonmetallic frame mitigates risk of corrosion betweensurgical valve and transcatheter valve stent materials. Home Mosaic & Mosaic Ultra Bioprostheses. Smooth, even brushing strokes should prevent inadvertent breakage. Consumers and health professionals are encouraged to report problems with medical devices. Older mechanical valves (such as Bj, rk-Shiley or caged-ball models,including some made ofstainless steel) may rarely be encountered, but like their modern counterparts are considered, Most common surgically implanted annuloplasty devices haveno metallic components and are, at all field strengths. The asymmetrical design of Mosaic offers one wider leafletspaced at 135 with an interstrut distance of 18.4 mm. Your use of the other site is subject to the terms of use and privacy statement on that site. Mosaic and Mosaic Ultra Bioprostheses. Indications, Safety, & Warnings. Medtronic Australasia has updated both the iEOA Mosaic Aortic Bioprosthesis sizing chart and Mosaic obturators/sizers. At a minimum, the following precautions must be taken: Following surgery, both surgeon and patient must be alert to any sign of adverse effects from surgery and the patient should be advised of the proper care of the operative ear. Healthcare Professionals Training, education andcollaboration on the treatment of mitral and tricuspidvalve disease. The artificial valve incorporates synthetic materials and porcine heart valve tissue. Important Labeling Information for United States. Serious complications may arise either during or after surgery which may result in irreparable damage to these otologic structures and their functions causing irreversible partial or total loss of hearing.
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