BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Replacement Heart-Valve

    PMA: P980043 · Supplement: S015 · Decision Dec 12, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11

    Basic Information

    Device Name
    Replacement Heart-Valve
    Trade Name
    HANCOCK II PORCINE BIOPROSTHESIS, MODELS T505 AND T510
    PMA Number
    P980043
    Supplement Number
    S015
    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
    December 12, 2007
    Date Received
    November 13, 2007
    Supplement Type
    Special (Immediate Track)
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE ADDITION OF A CAUTION STATEMENT TO THE LABELING.

    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