[Federal Register Volume 83, Number 92 (Friday, May 11, 2018)]
[Notices]
[Pages 22080-22081]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-10050]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-1726]


Circulatory System Devices Panel of the Medical Devices Advisory 
Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) announces a forthcoming 
public advisory committee meeting of the Circulatory System Devices 
Panel of the Medical Devices Advisory Committee. The general function 
of the committee is to provide advice and recommendations to the Agency 
on FDA's regulatory issues. The meeting will be open to the public.

DATES: The meeting will be held on June 12, 2018, from 8 a.m. to 6 p.m.

ADDRESSES: Hilton Washington, DC North/Gaithersburg, Salons A, B, C, 
and D, 620 Perry Pkwy., Gaithersburg, MD 20877. The hotel's telephone 
number is 301-977-8900. Answers to commonly asked questions including 
information regarding special accommodations due to a disability, 
visitor parking, and transportation may be accessed at: https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm.

FOR FURTHER INFORMATION CONTACT: Evella Washington, Center for Devices 
and Radiological Health, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 66, Rm. G640, Silver Spring, MD 20993-0002, 
[email protected]; 301-796-6683, or FDA Advisory Committee 
Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC 
area). A notice in the Federal Register about last minute modifications 
that impact a previously announced advisory committee meeting cannot 
always be published quickly enough to provide timely notice. Therefore, 
you should always check the Agency's website at https://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate 
advisory committee meeting link, or call the advisory committee

[[Page 22081]]

information line to learn about possible modifications before coming to 
the meeting.

SUPPLEMENTARY INFORMATION: 
    Agenda: On June 12, 2018, the committee will discuss, make 
recommendations, and vote on the premarket approval application 
sponsored by Cordis, Inc. for the INCRAFT AAA Stent Graft System, which 
is intended for the endovascular treatment of infra-renal abdominal 
aortic aneurysms in patients with appropriate anatomy. The INCRAFT 
device is being evaluated in the INSPIRATION study, a multicenter, 
prospective, non-randomized investigation. The study met its primary 
safety and effectiveness endpoints, but results also showed higher than 
anticipated rates of certain adverse events. The committee discussion 
will focus on how these events impact the long-term safety and 
effectiveness, as well as the benefit/risk profile of the device.
    FDA intends to make background material available to the public no 
later than 2 business days before the meeting. If FDA is unable to post 
the background material on its website prior to the meeting, the 
background material will be made publicly available at the location of 
the advisory committee meeting, and the background material will be 
posted on FDA's website after the meeting. Background material is 
available at https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting 
link.
    Procedure: Interested persons may present data, information, or 
views, orally or in writing, on issues pending before the committee. 
Written submissions may be made to the contact person on or before June 
5, 2018. Oral presentations from the public will be scheduled on June 
12, 2018, between approximately 1 p.m. and 2 p.m. Those individuals 
interested in making formal oral presentations should notify the 
contact person and submit a brief statement of the general nature of 
the evidence or arguments they wish to present, the names and addresses 
of proposed participants, and an indication of the approximate time 
requested to make their presentation on or before May 25, 2018. Time 
allotted for each presentation may be limited. If the number of 
registrants requesting to speak is greater than can be reasonably 
accommodated during the scheduled open public hearing session, FDA may 
conduct a lottery to determine the speakers for the scheduled open 
public hearing session. The contact person will notify interested 
persons regarding their request to speak by May 29, 2018.
    Persons attending FDA's advisory committee meetings are advised 
that the Agency is not responsible for providing access to electrical 
outlets.
    FDA welcomes the attendance of the public at its advisory committee 
meetings and will make every effort to accommodate persons with 
disabilities. If you require accommodations due to a disability, please 
contact AnnMarie Williams at [email protected], 301-796-
5966 at least 7 days in advance of the meeting.
    FDA is committed to the orderly conduct of its advisory committee 
meetings. Please visit our website at https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures 
on public conduct during advisory committee meetings.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: May 7, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-10050 Filed 5-10-18; 8:45 am]
 BILLING CODE 4164-01-P