BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Replacement Heart-Valve

    PMA: P860057 · Supplement: S130 · Decision Jan 12, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11

    Basic Information

    Device Name
    Replacement Heart-Valve
    Trade Name
    CARPENTIER-EDWARDS PERIMOUNT PERICARDIIAL AORTIC BIOPROSTHESIS, THEON PERICARDINAL AORTIC BIOPROSTHESIS WITH THERMAFIX T
    PMA Number
    P860057
    Supplement Number
    S130
    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 12, 2015
    Date Received
    December 22, 2014
    Supplement Type
    Special (Immediate Track)
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR AN ADDITIONAL GLUTERALDEHYDE CHANGE-OUT STEP IN THE MANUFACTURING PROCESS AND RELATED MANUFACTURING PROCEDURE UPDATES TO REFLECT THIS NEW STEP.

    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