Document ID: FDA-2010-N-0001-0067
Agency: fda
Document Type: Notice
Title: Ophthalmic Devices Panel of the Medical Devices Advisory Committee
Posted Date: 2010-06-22T04:00Z

[Federal Register: June 22, 2010 (Volume 75, Number 119)]
[Notices]               
[Page 35495-35496]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr22jn10-61]                         

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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]
BILLING CODE 4160-01-S