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| Name of Committee | Obstetrics and Gynecology Devices Panel |
| Date and Time | The meeting was held on the following dates:
Aug 29, 06 8:00 AM - 5:00 PM
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| Location | Hilton Washington D.C. North/Gaithersburg, Montgomery Ballroom
620 Perry Parkway
Gaithersburg
, MD |
| Contact Information | Michael Bailey, Center for Devices and Radiological Health (HFZ-470), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-1180 or FDA Advisory Committee Information Hotline, 1-800-741-8138 (301-443-0572 in the Washington, DC area), code 3014512524. Please call the Information Line for up-to-date information on this meeting. |
| Agenda | The committee will discuss, make recommendations, and vote on a premarket approval application for a non-invasive device for use as a complement to clinical breast examination in asymptomatic women between the ages of 30-39. Background information, including the agenda and questions for the committee, will be available to the public 1 business day before the meeting on the Internet at http://www.fda.gov/cdrh/panel (click on Upcoming CDRH Advisory Panel/Committee Meetings). |
| 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 August 22, 2006. Oral presentations from the public will be scheduled between approximately 8:15 a.m. and 8:45 a.m., and between approximately 3:30 p.m. and 4 p.m. Time allotted for each presentation may be limited. 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 August 22, 2006. |
| | Persons attending FDA’s advisory committee meetings are advised that the agency is not responsible for providing access to electrical outlets. |
| Conduct | FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at http://www.fda.gov/oc/advisory/ for procedures on public conduct during advisory committee meetings. |
| Related Documents |
| Agenda: | Draft Agenda for August 29, 2006 Meeting |  |
| Agenda: | Final Agenda for August 29, 2006 Meeting | |
| Brief Summary: | Brief Summary for August 29, 2006 Meeting |  |
| Briefing: | Briefing Information for August 29, 2006 Meeting | |
| Minutes: | Final Summary Minutes for August 29, 2006 Meeting | |
| Questions: | Draft Questions for August 29, 2006 Meeting | |
| Questions: | Final Questions for August 29, 2006 Meeting | |
| Roster: | Final Roster for August 29, 2006 Meeting | |
| Roster: | Draft Roster for August 29, 2006 Meeting | |
| Slides: | Slides for August 29, 2006 Meeting | |
| Transcript: | Transcript for August 29, 2006 Meeting - Pages 1 - 100 | |
| Transcript: | Transcript for August 29, 2006 Meeting - Pages 101 - 200 | |
| Transcript: | Transcript for August 29, 2006 Meeting - Pages 201 - 300 | |
| Transcript: | Transcript for August 29, 2006 Meeting - Pages 301 - 372 | |
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| Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). |
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