BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Aortic Valve, Prosthesis, Percutaneously Delivered

    PMA: P130021 · Supplement: S109 · Decision Apr 29, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24

    Basic Information

    Device Name
    Aortic Valve, Prosthesis, Percutaneously Delivered
    Trade Name
    Medtronic CoreValve Evolut R System, Medtronic CoreValve Evolut PRO System, Medtronic Evolut PRO+ System, Medtronic Evol
    PMA Number
    P130021
    Supplement Number
    S109
    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
    April 29, 2022
    Date Received
    January 28, 2022
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    Approval for 1) modifications to the Medtronic Evolut FX Instructions for Use to include the clinical data; and 2) reformatting the clinical study summaries and revising the legal manufacturer address in the IFUs for the Evolut R, Evolut PRO, Evolut PRO+, and Evolut FX Systems.

    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