[Federal Register: December 26, 2006 (Volume 71, Number 247)]
[Page 77402-77403]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

Neurological Devices Panel of the Medical Devices Advisory 
Committee; Amendment of Notice

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.


    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.

FOR FURTHER INFORMATION CONTACT: Janet L. Scudiero, Center for Devices 
and Radiological Health (HFZ-410), Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850, 240-276-3737, or FDA Advisory 
Committee Information Line, 1-800-741-8138 (301-443-0572 in the 
Washington, DC area), code 3014512513. Please call the Information Line 
for up-to-date information on this meeting.

SUPPLEMENTARY 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. 

[[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 treatment-resistant 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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ohrms/dockets/ac/acmenu.htm, click on 

the year 2007 and scroll down to the appropriate advisory committee 
    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. E6-21995 Filed 12-22-06; 8:45 am]