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| Name of Committee | Circulatory System Devices Panel |
| Date and Time | The meeting was held on the following dates:
Mar 1, 07 8:00 AM - 5:30 PM
Mar 2, 07 8:00 AM - 6:00 PM
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| Location | Hilton Washington DC North/Gaithersburg, Salons A, B and C
620 Perry Parkway
Gaithersburg
, MD |
| Contact Information | James Swink, Center for Devices and Radiological Health (HFZ-450), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 240-276-4179, or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), code 3014512625. Please call the Information Line for up-to-date information on this meeting. |
| Agenda | On March 1, 2007, the committee will discuss and make recommendations regarding the premarket approval application, sponsored by Medtronic Inc., for the Chronicle Implantable Hemodynamic Monitoring System. This implantable device is intended to reduce hospitalization events or equivalent events for worsening heart failure in patients with moderate to advanced heart failure. On March 2, 2007, the committee will discuss and make recommendations regarding clinical trial designs for Patent Foreman Ovale closure devices intended to prevent recurrent stroke. FDA intends to make background material available to the public no later than 1 business day 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/ohrms/dockets/ac/acmenu.htm, click on the year 2007 and scroll down to the appropriate advisory committee link. |
| Procedure | On March 1, 2007, from 8 a.m. to 5:30 p.m., and March 2, 2007, from 8 a.m. to 10 a.m. and 12 p.m. to 6 p.m., the meeting is open to the public. 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 beofre February 23, 2007. Oral presentations from the public will be scheduled for approximately 30 minutes at the beginning of committee deliberations for each topic and for approximately 30 minutes near the end of the committee deliberations on each day. 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 February 15, 2007. 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 February 16, 2007. |
| Closed Committee Information | On March 2, 2007, from 10 a.m. to 12 p.m., the meeting will be closed to permit the discussion and review of trade secret and/or confidential information (5 U.S.C. 552b(c)(4)) presented by sponsors. |
| | 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 - March 1, 2007 Meeting |  |
| Agenda: | Draft Agenda - March 2, 2007 Meeting | |
| Brief Summary: | March 1, 2007 Meeting |  |
| Brief Summary: | March 2, 2007 Meeting | |
| Briefing: | March 1, 2007 Meeting | |
| Briefing: | March 2, 2007 Meeting | |
| Minutes: | Final Minutes for March 1, 2007 Meeting | |
| Notice of Meeting: | March 1-2, 2007 Meeting | |
| Other: | Nature and Basis Statements of Conflict(s) of Interest for the March 1 - 2, 2007 Meeting | |
| Questions: | March 1, 2007 Meeting | |
| Questions: | March 2, 2007 Meeting | |
| Roster: | Draft Roster - March 1, 2007 Meeting | |
| Roster: | Draft Roster - March 2, 2007 Meeting | |
| Transcript: | Transcript for March 1, 2007 Meeting | |
| Transcript: | Transcript for March 1, 2007 Meeting | |
| Transcript: | Transcript for March 1, 2007 Meeting | |
| Transcript: | Transcript for March 1, 2007 Meeting | |
| Transcript: | Transcript for March 1, 2007 Meeting | |
| Transcript: | Transcript for March 2, 2007 |  |
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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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