Federal Register: December 26, 2006 (Volume 71, Number 247)
DOCID: FR Doc E6-21995
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
NOTICE: NOTICES
ACTION: Meetings:
DOCUMENT ACTION: Notice.
SUBJECT CATEGORY:
Neurological Devices Panel of the Medical Devices Advisory Committee; Amendment of Notice
DOCUMENT SUMMARY:
The Food and Drug Administration (FDA) is announcing an amendment to the notice of the meeting of the Neurological Devices Panel of the Medical Devices Advisory Committee. This meeting was originally announced in the Federal Register of December 6, 2006 (71 FR page 70780). The amendment is being made to reflect a change in the Agenda portion of the document, specifically to include the name of the sponsors and devices. There are no other changes.
SUMMARY:
Medical Devices Advisory Committee,
DOCUMENT BODY:
The Food and Drug Administration (FDA) is announcing an amendment to the notice of the meeting of the Neurological Devices Panel of the Medical Devices Advisory Committee. This meeting was originally announced in the Federal Register of December 6, 2006 (71 FR page 70780). The amendment is being made to reflect a change in the Agenda portion of the document, specifically to include the name of the sponsors and devices. There are no other changes.
SUPPLEMENTAL INFORMATION
In the Federal Register of December 6, 2006, FDA announced that a meeting of the Neurological Devices Panel of the Medical Devices Advisory Committee would be held on January 26, 2007. On page 70780, column 1, the Agenda portion of the document is amended to read as follows:
Agenda: The committee will discuss and make recommendations on a
premarket notification application, sponsored by Neuronetics, Inc., for
the NeuroStar System for the treatment of major depressive disorder. The
[[Page 77403]]
committee will also hear and discuss post approval study reports for
two recently approved neurological device premarket approval
applications: The VNS Therapy\TM\ System, sponsored by Cyberonics,
Inc., for treatmentresistant chronic or recurrent depression; and the
Dural Sealant System, sponsored by Confluent Surgical, Inc., for use as
an adjunct to sutured dural repair during cranial surgery to provide watertight closure.
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.
This notice is issued under the Federal Advisory Committee Act (5 U.S.C. app.2) and 21 CFR part 14, relating to the advisory committees.
Dated: December 18, 2006.
Randall W. Lutter,
Associate Commissioner for Policy and Planning.
[FR Doc. E621995 Filed 122206; 8:45 am]
BILLING CODE 416001S
FOR FURTHER INFORMATION CONTACT
Janet L. Scudiero, Center for Devices and Radiological Health (HFZ410), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 2402763737, or FDA Advisory Committee Information Line, 18007418138 (3014430572 in the Washington, DC area), code 3014512513. Please call the Information Line for uptodate information on this meeting.