BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Aortic Valve, Prosthesis, Percutaneously Delivered

    PMA: P130021 · Supplement: S004 · Decision Sep 2, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24

    Basic Information

    Device Name
    Aortic Valve, Prosthesis, Percutaneously Delivered
    Trade Name
    MEDTRONIC COREVALVE (R) SYSTEM
    PMA Number
    P130021
    Supplement Number
    S004
    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
    September 2, 2014
    Date Received
    April 10, 2014
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A NEW COMPRESSION LOADING SYSTEM (G4 CLS), A MANUFACTURING SITE LOCATED AT SYNERGY HEALTH WESTPORT LIMITED, SYNERGY HEALTH PLACE, LODGE ROAD, WESTPORT,CO., MAYO, IRELAND, AND THE GAMMA STERILIZATION OF THE FINISHED G4 CLS.

    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