BEUDAMED
    FDA PMA FDA Class 3 Approved (Withdrawn) 🇺🇸 United States

    Replacement Heart-Valve

    PMA: P870056 · Decision Sep 25, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11

    Basic Information

    Device Name
    Replacement Heart-Valve
    Trade Name
    CARPENTIER-EDWARDS BIOPROSTHESES MODELS 2625&6625
    PMA Number
    P870056
    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    Approved (Withdrawn)
    Decision Code
    APWD
    Decision Date
    September 25, 1991
    Date Received
    September 24, 1987
    Expedited Review
    N
    Docket Number
    91M-0395

    Advisory Committee Statement

    Approval for the Carpentier-Edwards® Bioprosthesis, Models 2625 (aortic) and 6625 (mitral). This device is intended for use in patients whose aortic or mitral valvular disease is sufficiently advanced to warrant replacement of their natural valve with a prosthetic one. It is also intended for use in patients with a previously implanted aortic or mitral valve prosthesis which is no longer functioning adequately and requires replacement.

    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