BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Replacement Heart-Valve

    PMA: P980043 · Decision Sep 28, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11

    Basic Information

    Device Name
    Replacement Heart-Valve
    Trade Name
    HANCOCK II PORCINE BIOPROSTHESIS
    PMA Number
    P980043
    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
    September 28, 1999
    Date Received
    October 29, 1998
    Expedited Review
    N
    Docket Number
    99M-4279

    Advisory Committee Statement

    Approval for the Medtronic Hancock(R) II Bioprosthetic Heart Valve, Models T505 (odd sizes 21 through 29 mm) and T510 (odd sizes 25 through 33 mm). This device is indicated for the replacement of pathologic or prosthetic aortic and mitral 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