BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Replacement Heart-Valve

    PMA: P990064 · Decision Jul 14, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11

    Basic Information

    Device Name
    Replacement Heart-Valve
    Trade Name
    MEDTRONIC MOSAIC PORCINE BIOPROSTHETIC HEART VALVE
    PMA Number
    P990064
    Device Class
    FDA Class 3
    Product Code
    DYE
    Generic Name
    replacement Heart-valve
    Regulation Number
    870.3925
    Medical Specialty
    Cardiovascular
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    July 14, 2000
    Date Received
    October 8, 1999
    Expedited Review
    N
    Docket Number
    00M-1416

    Advisory Committee 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.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    DYE Replacement Heart-Valve