FDA / General & Plastic Surgery Devices Panel Meeting

[Guest guest]

CDRH Home

|

Search

|

A-Z Index

|

Feedback

Prototype - for testing only

510(k)

|

Registration

|

Listing

|

Adverse Events

|

PMA

|

Classification

|

CLIA

CFR Title 21

|

Advisory Committees

|

Assembler

|

NHRIC

|

Guidance

|

Standards

New Search

Back To Search Results

This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public.

Name of Committee

General and Plastic Surgery Devices Panel

Date and Time

The meeting will be held on the following dates:Feb 28, 2003 8:00 AM - 5:00 PM

Location

Hilton Washington DC North/Gaithersburg, Salons A, B & C620 ParkwayGaithersburg , MD

Hotel Accommodations

A block of sleeping rooms has been reserved at the Hilton Washington DC North - Gaithersburg, 620 Parkway, Gaithersburg, MD (phone: 301-977-8900) for arrival on February 27, 2003 and departure on February 28, 2003. Rooms not reserved by February 7, 2003 will be released back to the hotel. Please reference FDA’s General and Plastic Surgery Devices Panel when making your reservation.

Disability Accommodations

FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact AnnMarie , Conference Management Staff, at 301-594-1283, ext. 113, at least 7 days in advance of the meeting.

Contact Information

Krause, Center for Devices and Radiological Health (HFZ-410), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-3090, ext. 141, or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), code 12519. Please call the Information Line or access the Internet address of http://www.fda.gov/cdrh/panelmtg.html for up-to-date information on this meeting.

Agenda

The committee will discuss, make recommendations, and vote on a premarket approval application for an injectable wrinkle treatment device. There will also be a discussion of two general issues: (1) clinical trial issues for devices designed for ablation of pulmonary tumors, and 2) clinical trial issues for devices designed for the treatment of emphysema. Background information for each topic, including the agenda and questions for the committee, will be available to the public one business day before the meeting on the Internet at http://www.fda.gov/cdrh/panelmtg.html. The material for this meeting will be posted on February 27, 2003.

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 by February 14, 2003. Oral presentations from the public will be scheduled between approximately 8:30 a.m. and 8:45 a.m., 11:30 a.m. and 11:45 a.m., and between approximately 3:30 p.m. and 4 p.m. Time allotted for oral public presentations may be limited. Those desiring to make formal oral presentations should notify the contact person before February 14, 2003, 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.

Persons attending FDA’s advisory committee meetings are advised that the agency is not responsible for providing access to electrical outlets.

Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2).

CDRH Home | Search | A-Z Index | Feedback | Accessibility | Disclai

FYI!

Martha Murdock, DirectorNational Silicone Implant Foundation | Dallas Headquarters"Supporting Survivors of Medical Implant Devices"4416 Willow LaneDallas, TX 75244-7537