Approval Order Statement APPROVAL FOR THE MOSAIC(R) PORCINE BIOPROSTHESIS, MODELS 305 AND 310 IN THE FOLLOWING SIZES: MODEL 305 (AORTIC) 21, 23, 25, 27 AND 29 MM; MODEL 310 (MITRAL) 25, 27, 29 AND 31 MM. THIS DEVICE IS INDICATED FOR THE REPLACEMENT OF MALFUNCTIONING NATIVE OR PROSTHETIC AORTIC AND MITRAL HEART VALVES. |