BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    System, Endovascular Graft, Aortic Aneurysm Treatment

    PMA: P040002 · Supplement: S013 · Decision Feb 21, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    34
    Registration Numbers
    34

    Basic Information

    Device Name
    System, Endovascular Graft, Aortic Aneurysm Treatment
    Trade Name
    POWERLINK SYSTEM ANEURYSM STENT GRAFT
    PMA Number
    P040002
    Supplement Number
    S013
    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 21, 2008
    Date Received
    December 26, 2007
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Location Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR AN ALTERNATE STERILIZATION SITE LOCATED AT STERIGENICS US, INC., LOS ANGELES, CALIFORNIA.

    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