BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Aortic Valve, Prosthesis, Percutaneously Delivered

    PMA: P130021 · Supplement: S014 · Decision Jun 22, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24

    Basic Information

    Device Name
    Aortic Valve, Prosthesis, Percutaneously Delivered
    Trade Name
    COREVALVE (TM) EVOLUT(TM) R SYSTEM
    PMA Number
    P130021
    Supplement Number
    S014
    Device Class
    FDA Class 3
    Product Code
    NPT
    Generic Name
    Aortic valve, prosthesis, percutaneously delivered
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    June 22, 2015
    Date Received
    April 23, 2015
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A DESIGN ITERATION OF THE 23, 26, AND 29 MM MEDTRONIC COREVALVE SYSTEM. THE NEW COMPONENTS INCLUDE COREVALVE EVOLUT R TRANSCATHETER AORTIC VALVES, MODELS EVOLUTR-23-US, EVOLUTR-26-US, AND EVOLUTR-29-US, ENVEO R DELIVERY CATHETER SYSTEM, MODEL ENVEOR-US, AND ENVEO R LOADING SYSTEMS, MODELS LS-ENVEOR-23US AND LS-ENVEOR-2629US. THESE COMPONENTS WILL BE MARKETED UNDER THE TRADE NAME COREVALVE EVOLUT R SYSTEM.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    NPT Aortic Valve, Prosthesis, Percutaneously Delivered