BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    System, Endovascular Graft, Aortic Aneurysm Treatment

    PMA: P990017 · Supplement: S011 · Decision Sep 20, 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 ENDOVASCULAR GRAFT TUBE AND BIFURCATED SYSTEMS
    PMA Number
    P990017
    Supplement Number
    S011
    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
    September 20, 2001
    Date Received
    September 25, 2000
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Postapproval Study Protocol
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR MODIFICATIONS TO THE FIVE YEAR FOLLOW-UP PROTOCOL: A) CHANGING THE FOLLOW-UP SCHEDULE; B) REMOVING THE ULTRASOUND AND ANKLE BRACHIAL INDICES (ABI) ASSESSMENTS; C) REPLACING THE ANNUAL PHYSICAL EXAM FOR CONTROL PATIENTS WITH AN ANNUAL TELEPHONE SURVEY AND COMPUTED TOMOGRAPHY (CT) AND PHYSICAL EXAM AT THE FIVE YEAR MARK; D) ALLOWING AN OPTIONAL TELEPHONE SURVEY FOR PATIENTS UNABLE OR UNWILLING TO COME TO THE INVESTIGATIONAL SITE; AND E) EXCLUDING PATIENTS WHO HAVE BEEN CONVERTED FROM FURTHER STUDY FOLLOW-UP.

    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