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18 dicembre 2020 06:30 Fonte: Adnkronos #salute-e-benessere TAMPA, Fla., Dec. 17, 2020 /PRNewswire/ -- Concept Medical Inc. (CMI) has been granted "Breakthrough Device Designation" from the Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA) for the MagicTouch SCB Sirolimus Coated Balloon Catheter, for the treatment of small coronary artery lesions in Coronary Artery Disease (CAD). The proposed indication for use includes "The MagicTouch SCB Sirolimus Coated Balloon Catheter is indicated for percutaneous transluminal coronary angioplasty, after appropri...

(1) TAMPA, Fla., Dec. 17, 2020 /PRNewswire/ -- Concept Medical Inc. (CMI) has been granted "Breakthrough Device Designation" from the Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA) for the MagicTouch SCB Sirolimus Coated Balloon Catheter, for the treatment of small coronary artery lesions in Coronary Artery Disease (CAD). The proposed indication for use includes "The MagicTouch SCB Sirolimus Coated Balloon Catheter is indicated for percutaneous transluminal coronary angioplasty, after appropriate vessel preparation, of small coronary artery lesion ...