BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Replacement Heart-Valve

    PMA: P860057 · Supplement: S001 · Decision Jan 4, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11

    Basic Information

    Device Name
    Replacement Heart-Valve
    Trade Name
    CARPENTIER-EDWARDS PERICARDIAL BIOPROSTHESIS, MODEL 2700
    PMA Number
    P860057
    Supplement Number
    S001
    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 4, 1996
    Date Received
    August 22, 1994
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A NAME CHANGE TO THE CARPENTIER-EDWARDS PERIMOUNT BIOPROSTHESIS, MODEL 2700, AND APPROVAL FOR A REDUCED SEWING RING (RSR) VERSION OF THE VALVE WHICH WILL BE NAMED THE CARPENTIER-EDWARDS PERIMOUNT RSR BIOPROSTHESIS, MODEL 2800 AND APPROVAL FOR THE USE OF THE CURRENT MODEL 1161 VALVE SIZERS WITH THE MODEL 2800 VALVE, AND APPROVAL FOR A NEW SET OF VALVE SIZERS, MODEL 1127, FOR USE WITH THE MODEL 2700 VALVE. THE APPROVAL ALSO DISCONTINUES THE USE FO THE CURRENT DEVICE NAME, THE CARPENTIER-EDWARDS PERICARDIAL BIOPROSTHESIS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE ANEM CARPENTIER-EDWARDS PERIMOUNT BIOPROSTHESIS, MODEL 2700, AND CARPENTIER-EDWARDS PERIMOUNT RSR BIOPROSTHESIS, MODEL 2800 AND WILL CONTINUE TO USE THE SAME INDICATIONS FOR USE AND REMAIN AVAILABLE IN THE AORTIC SIZES OF 19, 21, 23, 25, 27, AND 29MM

    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