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    FDA PMA FDA Class 3 Approved (Withdrawn) 🇺🇸 United States

    Replacement Heart-Valve

    PMA: P000007 · Decision Feb 27, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11

    Basic Information

    Device Name
    Replacement Heart-Valve
    Trade Name
    EDWARDS PRIMA PLUS STENTLESS BIOPROSTHESIS MODEL 2500P
    PMA Number
    P000007
    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    Approved (Withdrawn)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
    February 27, 2001
    Date Received
    January 27, 2000
    Expedited Review
    N
    Docket Number
    01M-0381

    Advisory Committee Statement

    APPROVAL FOR THE EDWARDS PRIMA(TM) PLUS STENTLESS BIOPROSTHESIS MODEL 2500P, SIZES 21, 23, 25 AND 27 MM. THE DEVICE IS INDICATED FOR PATIENTS WHO REQUIRE REPLACEMENT OF THEIR NATIVE OR PROSTHETIC AORTIC VALVE USING THE SUBCORONARY IMPLANTATION TECHNIQUE.

    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