BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Replacement Heart-Valve

    PMA: P980043 · Supplement: S034 · Decision Jan 10, 2013
    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
    Supplement Number
    S034
    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
    January 10, 2013
    Date Received
    March 23, 2012
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE GLUTARALDEHYDE STOCK SOLUTION THAT IS OBTAINED FROM DOWCHEMICAL FOR THE FIXATIVE, STORAGE, AND STERILIZATION SOLUTIONS TO BE CHANGED FROM A 25% STOCK SOLUTION TO A 50% STOCK SOLUTION.

    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