BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Replacement Heart-Valve

    PMA: P980043 · Supplement: S009 · Decision Jun 5, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11

    Basic Information

    Device Name
    Replacement Heart-Valve
    Trade Name
    HANCOCK II BIOPROSTHESIS, MODELS T505 AND T510
    PMA Number
    P980043
    Supplement Number
    S009
    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
    June 5, 2006
    Date Received
    February 6, 2006
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR MODIFICATIONS TO: 1) THE JAR RETAINER USED FOR BOTH THE MITRAL AORTIC CONFIGURATIONS OF HANCOCK II BIOPROSTHESES; 2) THE SERIAL NUMBER TAG FOR MITRAL AND AORTIC CONFIGURATIONS OF THE HANCOCK II BIOPROSTHESES; 3) THE VALVE HOLDER FOR THE HANCKCK II MITRAL BIOPROTHESES; AND 4) THE "INSTRUCTIONS FOR USE" TO ACCOMMODATE THE CHANGES IN THE RETAINER, TAG AND MITRAL HOLDER.

    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