Advisory Committees

December 2-3, 2010: Gastroenterology and Urology Devices Panel Meeting Announcement



Food and Drug Administration

[Docket No. FDA–2010–N–0001]

Gastroenterology and Urology Devices Panel of the Medical Devices

Advisory Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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: Gastroenterology and Urology 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 December 2 and 3, 2010,

from 8 a.m. to 6 p.m.

Location: Hilton Washington DC North/Gaithersburg, Ballroom, 620 Perry

Pkwy., Gaithersburg, MD.

Contact Person: Margaret McCabe-Janicki, Food and Drug Administration,

Center for Devices and Radiological Health, 10903 New Hampshire Ave., Bldg.

66, rm. 1535, Silver Spring, MD 20993–0002, 301–796–7029, or FDA Advisory

Committee Information Line, 1–800–741–8138 (301–443–0572 in the

Washington, DC area), code 3014512523. 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 December 2, 2010, the committee will discuss, make

recommendations, and vote on information related to the premarket approval

application (PMA) for SOLESTA, sponsored by Oceana Therapeutics, Inc.

SOLESTA is indicated for the treatment of fecal incontinence in patients who

have failed conservative therapy. On December 3, 2010, the committee will

discuss, make recommendations, and vote on information related to the PMA

for the LAP-BAND Adjustable Gastric Banding System, sponsored by Allergan.

The sponsor is requesting an expanded Indication for Use for their LAP-BAND

Adjustable Gastric Banding System to include weight reduction in patients

with a Body Mass Index (BMI) of at least 35 kg/m2 or a BMI of at least 30

kg/m2 with one or more comorbid conditions.

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

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 November 18,

2010. Oral presentations from the public will be scheduled between

approximately 1 p.m. and 2 p.m. on December 2 and 3, 2010. 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 November 10, 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 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 November 11, 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,

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

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: September 17, 2010.

Jill Hartzler Warner,

Acting Associate Commissioner for Special Medical Programs.

Page Last Updated: 08/11/2015
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