[Federal Register Volume 75, Number 119 (Tuesday, June 22, 2010)]
[Notices]
[Pages 35495-35496]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-15020]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0001]
Ophthalmic Devices Panel of the Medical Devices Advisory
Committee; Notice of Meeting
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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This notice announces a forthcoming meeting of a public advisory
committee of the Food and Drug Administration (FDA). The meeting will
be open to the public.
Name of Committee: Ophthalmic Devices Panel of the Medical Devices
Advisory Committee.
General Function of the Committee: To provide advice and
recommendations to the agency on FDA's regulatory issues.
Date and Time: The meeting will be held on July 30, 2010, from 8
a.m. to 6 p.m.
Location: Holiday Inn, Ballroom, 2 Montgomery Village Ave.,
Gaithersburg, MD.
Contact Person: James Engles, Center for Devices and Radiological
Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
66, rm. 1566, Silver Spring, MD 20993-0002, or FDA Advisory Committee
Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC
area), code 3014512396. Please call the Information Line for up-to-date
information on this meeting. 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 Web site
and call the appropriate advisory committee hot line/phone line to
learn about possible modifications before coming to the meeting.
Agenda: On July 30, 2010, the committee will discuss, make
recommendations, and vote on a premarket approval application for the
Glaukos iStent Trabecular Micro-Bypass Stent, Model GTS-100 L/R,
sponsored by Glaukos Corp. The device is indicated for use in
conjunction with cataract surgery for the reduction of intraocular
pressure (IOP) in subjects with mild to moderate open-angle glaucoma
currently treated with ocular hypotensive medication. For this device,
the patients should have normal gonioscopic anatomy and a visually
significant cataract eligible for phacoemulsification. The patient's
glaucoma should be considered mild to moderate Primary Open Angle
Glaucoma, or the secondary open angle glaucomas, Pigmentary Glaucoma
and Pseudoexfoliation Glaucoma. Patients with other causes of secondary
open angle glaucoma or angle closure glaucomas are not eligible for use
of this device. Patients' IOP should be controlled on 1-3 glaucoma
medications and patients should not previously have had surgery for
glaucoma.
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 Web site 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 Web site after the meeting. Background material is
available at http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee 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 July
22, 2010. Oral presentations from the public will be scheduled
approximately between 1 p.m. and 2 p.m. or immediately following lunch.
Those desiring to make 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 July 14, 2010. 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
[[Page 35496]]
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 July 15, 2010.
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
physical disabilities or special needs. If you require special
accommodations due to a disability, please contact AnnMarie Williams,
Conference Management Staff, at 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 Web site at http://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: June 15, 2010.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2010-15020 Filed 6-21-10; 8:45 am]
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