Legal Status
Legal Status
Notice
Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting
A Notice by the Food and Drug Administration on
Document Details
Information about this document as published in the Federal Register.
- Printed version:
- Publication Date:
- 08/02/2004
- Agencies:
- Food and Drug Administration
- Document Type:
- Notice
- Document Citation:
- 69 FR 46156
- Page:
- 46156-46157 (2 pages)
- Document Number:
- 04-17446
Document Details
-
Enhanced Content - Table of Contents
This tables of contents is a navigational tool, processed from the headings within the legal text of Federal Register documents. This repetition of headings to form internal navigation links has no substantive legal effect.
Enhanced Content - Table of Contents
-
Enhanced Content - Submit Public Comment
- This feature is not available for this document.
Enhanced Content - Submit Public Comment
-
Enhanced Content - Read Public Comments
- This feature is not available for this document.
Enhanced Content - Read Public Comments
-
Enhanced Content - Sharing
- Shorter Document URL
- https://www.federalregister.gov/d/04-17446 https://www.federalregister.gov/d/04-17446
Enhanced Content - Sharing
-
Enhanced Content - Document Tools
These tools are designed to help you understand the official document better and aid in comparing the online edition to the print edition.
-
These markup elements allow the user to see how the document follows the Document Drafting Handbook that agencies use to create their documents. These can be useful for better understanding how a document is structured but are not part of the published document itself.
Display Non-Printed Markup Elements
Enhanced Content - Document Tools
-
-
Enhanced Content - Developer Tools
This document is available in the following developer friendly formats:
- JSON: Normalized attributes and metadata
- XML: Original full text XML
- MODS: Government Publishing Office metadata
More information and documentation can be found in our developer tools pages.
Enhanced Content - Developer Tools
Published Document
This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format.
AGENCY:
Food and Drug Administration, HHS.
ACTION:
Notice.
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.
Start Printed Page 46157Name of Committee: Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee.
General Function of the Committee: To provide advice and recommendations to the agency on FDA's regulatory issues.
Date and Time: The meeting will be held on August 31, 2004, from 8 a.m. to 4:30 p.m.
Location: Hilton Washington DC North/Gaithersburg, Ballroom Salons A, B, C, and D, 620 Perry Pkwy., Gaithersburg, MD.
Contact Person: Janet L. Scudiero, Center for Devices and Radiological Health (HFZ-410), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-1184, ext. 176, or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), code 3014512521. Please call the Information Line for up-to-date information on this meeting.
Agenda: The committee will discuss, make recommendations, and vote on a premarket approval application for an interspinous process distraction system intended for treatment of patients aged 50 or older suffering from neurogenic intermittent claudication secondary to mild or moderate lumbar spinal stenosis who have undergone a regimen of non-operative treatment. Background information for the topics, including the agenda and questions for the committee, will be available to the public 1 business day before the meeting on the Internet at http://www.fda.gov/cdrh/panelmtg.html.
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 August 17, 2004. Oral presentations from the public will be scheduled for approximately 30 minutes at the beginning of committee deliberations and for approximately 30 minutes near the end of the deliberations. Time allotted for each presentation may be limited. Those desiring to make formal oral presentations should notify the contact person before August 17, 2004, 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.
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 Shirley Meeks at 301-594-1283, ext.105, at least 7 days in advance of the meeting.
Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2).
Start SignatureDated: July 22, 2004.
William K. Hubbard,
Associate Commissioner for Policy and Planning.
[FR Doc. 04-17446 Filed 7-30-04; 8:45 am]
BILLING CODE 4160-01-S