BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    System, Endovascular Graft, Aortic Aneurysm Treatment

    PMA: P100021 · Supplement: S038 · Decision Jul 8, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    34
    Registration Numbers
    34

    Basic Information

    Device Name
    System, Endovascular Graft, Aortic Aneurysm Treatment
    Trade Name
    ENDURANT AND ENDURANT II STENT GRAFT SYSTEM
    PMA Number
    P100021
    Supplement Number
    S038
    Device Class
    FDA Class 3
    Product Code
    MIH
    Generic Name
    SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    July 8, 2014
    Date Received
    June 9, 2014
    Supplement Type
    Special (Immediate Track)
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR INTRODUCING A LAMP MANDREL AS A MANUFACTURING TOOL FOR RADIOPAQUE CONTRALATERAL GATE MARKER INSPECTION OF ENDURANT AND ENDURANT II BIFURCATED STENT GRAFTS AND A COIL DISPENSER AS A VISUAL AID DURING THE PRE-KITTING PROCESS OF ENDURANT II STENT GRAFTS.

    Classifications

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

    Product Code Device Name
    MIH System, Endovascular Graft, Aortic Aneurysm Treatment