Document ID: FDA-2010-N-0001-0123
Agency: fda
Document Type: Notice
Title: General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Amendment of Notice
Posted Date: 2010-10-05T04:00Z

[Federal Register Volume 75, Number 192 (Tuesday, October 5, 2010)]
[Notices]
[Page 61507]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-24983]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0001]

General and Plastic Surgery Devices Panel of the Medical Devices 
Advisory Committee; Amendment of Notice

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

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    The Food and Drug Administration (FDA) is announcing an amendment 
to the notice of meeting of the General and Plastic Surgery Devices 
Panel of the Medical Devices Advisory Committee. This meeting was 
announced in the Federal Register of August 16, 2010 (75 FR 49940). The 
amendment is being made to reflect a change in the Agenda portion of 
the document. There are no other changes.

FOR FURTHER INFORMATION CONTACT:  Margaret McCabe-Janicki, Center for 
Devices and Radiological Health, Food and Drug Administration, 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 3014512519. Please 
call the Information Line for up-to-date information on this meeting.

SUPPLEMENTARY INFORMATION: In the Federal Register of August 16, 2010, 
FDA announced that a meeting of the General and Plastic Surgery Devices 
Panel of the Medical Devices Advisory Committee would be held on 
November 18, 2010. On page 49940, in the second column, in the Agenda 
portion of the document, the first full paragraph is changed to read as 
follows:
    Agenda: On November 18, 2010, the committee will discuss, make 
recommendations, and vote on information related to the premarket 
approval application for MelaFind, sponsored by MELA Sciences. 
MelaFind(R) is a non-invasive and objective multi-spectral computer 
vision system designed to aid physicians in the detection of early 
melanoma from among clinically atypical (those having one or more 
clinical or historical characteristics of melanoma, such as asymmetry, 
border irregularity, color variegation, diameter greater than 6 
millimeters, evolving, patient concern, regression, and ``ugly 
duckling'') cutaneous pigmented lesions that are non-ulcerated, not 
bleeding, and less than 2.2 centimeters in diameter, when a physician 
chooses to obtain additional information before making a final decision 
to biopsy to rule out melanoma.
    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: September 30, 2010.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2010-24983 Filed 10-4-10; 8:45 am]
BILLING CODE 4160-01-S