BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Replacement Heart-Valve

    PMA: P870077 · Supplement: S051 · Decision Jun 11, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11

    Basic Information

    Device Name
    Replacement Heart-Valve
    Trade Name
    CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE, PORCINE MITRAL BIOPROSTHESIS, CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE MITRAL
    PMA Number
    P870077
    Supplement Number
    S051
    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 11, 2013
    Date Received
    December 14, 2012
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE USE OF THE RE-DESIGNED AND RE-PROGRAMMED SENSITECH TAGALERT TEMPERATURE ALARM INDICATION WITH NEW ELECTROMAGNETIC INFERENCE/ELECTROMAGNETIC DISCHARGE (EMI/ESE) PROTECTION IN THE DEVICES.

    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