BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    System, Endovascular Graft, Aortic Aneurysm Treatment

    PMA: P990017 · Supplement: S012 · Decision Feb 15, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    34
    Registration Numbers
    34

    Basic Information

    Device Name
    System, Endovascular Graft, Aortic Aneurysm Treatment
    Trade Name
    ANCURE TUBE AND BIFURCATED ENDOGRAFT SYSTEMS
    PMA Number
    P990017
    Supplement Number
    S012
    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
    February 15, 2001
    Date Received
    November 6, 2000
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A MODIFICATION TO THE TRAINING PROGRAM TO ALLOW LESS THAN 100% CASE SUPPORT AT CENTERS THAT MEET THE ESTABLISHED CRITERIA. THIS CHANGE AFFECTS THE CONDITIONS OF APPROVAL DESCRIBED IN THE ORIGINAL APPROVAL ORDER, DATED SUPTEMBER 28, 1999.

    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