BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Replacement Heart-Valve

    PMA: P860057 · Supplement: S016 · Decision Nov 29, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11

    Basic Information

    Device Name
    Replacement Heart-Valve
    Trade Name
    CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS
    PMA Number
    P860057
    Supplement Number
    S016
    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
    November 29, 2001
    Date Received
    November 17, 2000
    Supplement Type
    Normal 180 Day Track
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR CHANGES TO THE SUPPORT ASSEMBLY COMPONENTS OF THE SIZE 25, 27, 29, AND 31 MM VALVES. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME CARPENTIER-EDWARDS PERIMOUNT PLUS PERICARDIAL BIOPROSTHESIS, MODEL 6900P AND IS INDICATED FOR THE REPLACEMENT OF DISEASED, DAMAGED, OR MALFUNCTIONING NATIVE OR PROSTHETIC MITRAL HEART 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