BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    System, Endovascular Graft, Aortic Aneurysm Treatment

    PMA: P990017 · Supplement: S038 · Decision Aug 8, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    34
    Registration Numbers
    34

    Basic Information

    Device Name
    System, Endovascular Graft, Aortic Aneurysm Treatment
    Trade Name
    ANCURE SYSTEM
    PMA Number
    P990017
    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
    August 8, 2003
    Date Received
    February 10, 2003
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Postapproval Study Protocol
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE FORMAT TO BE USED FOR THE CLINICAL UPDATE THAT WILL BE PROVIDED TO PHYSICIANS USERS AT LEAST ANNUALLY. THE INFORMATION CONTAINED IN THIS UPDATE WILL BE PROVIDED TO THE FDA VIA THE PMA ANNUAL REPORT.

    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