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    FDA PMA FDA Class 3 Approved (Withdrawn) 🇺🇸 United States

    Replacement Heart-Valve

    PMA: P010041 · Decision Jun 24, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11

    Basic Information

    Device Name
    Replacement Heart-Valve
    Trade Name
    CARPENTIER-EDWARDS S.A.V. BIOPROSTHESIS, MODEL 2650 (AORTIC)
    PMA Number
    P010041
    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    Approved (Withdrawn)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
    June 24, 2002
    Date Received
    August 1, 2001
    Expedited Review
    N
    Docket Number
    03M-0086

    Advisory Committee Statement

    APPROVAL FOR THE CARPENTIER-EDWARDS S.A.V. BIOPROSTHESIS, MODEL 2650 (AORTIC), WHICH INCLUDES SIZES 21, 23, 25 AND 27MM. THIS DEVICE IS INDICATED FOR PATIENTS WHO REQUIRE REPLACEMENT OF THEIR NATIVE OR PROSTHETIC AORTIC VALVE.

    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