- February 19, 2016
03:00 AM - 01:00 PM EST
|CDRH||February 19, 2016||8:00 a.m. - 6:00 p.m.||Hilton Washington DC North
Salons A, B, C, and D
620 Perry Pkwy.
Gaithersburg, MD 20877
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2015-N-0001]
Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee; Amendment of Notice
AGENCY: Food and Drug Administration, HHS.
SUMMARY: The Food and Drug Administration (FDA) is announcing an amendment to the notice of meeting of the Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee. This meeting was announced in the Federal Register of November 23, 2015. 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: Sara Anderson, Center for Devices and Radiological Health, Food and Drug Administration, Bldg. 66, rm.1643, 10903 New Hampshire Ave., Silver Spring, MD 20993, Sara.Anderson@fda.hhs.gov, 301-796-7047, or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area). Please call the Information Line for up-to-date information on this meeting.
SUPPLEMENTARY INFORMATION: In the Federal Register of November 23, 2015, 80 FR 72971, FDA announced that a meeting of the Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee would be held on February 19, 2016. On page 72972, in the first column, the Agenda portion of the document is changed to read as follows:
The Committee will discuss, make recommendations, and vote on information regarding the premarket application (PMA) for the DIAM Spinal Stabilization System, sponsored by Medtronic Sofamor Danek USA. The DIAM Spinal Stabilization System is indicated for skeletally mature patients that have moderate low back pain (with or without radicular pain) with current episode lasting less than 1 year in duration secondary to lumbar degenerative disc disease (DDD) at a single symptomatic level from L2-L5. DDD is confirmed radiologically with one or more of the following factors: (1) Patients must have greater than 2 mm of decreased disc height compared to the adjacent level; (2) scarring/thickening of the ligamentum flavum, annulus fibrosis, or facet joint capsule; or (3) herniated nucleus pulposus. The DIAM device is implanted via a minimally invasive posterior approach.
FDA intends to make background material available to the public no later than 2 business days 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/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/default.htm. Scroll down to the appropriate advisory committee meeting 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 30, 2015.
Associate Commissioner for Policy.
FDA Advisory Committee Information Line
(301-443-0572 in the Washington DC area)
Please call the Information Line for up-to-date information on this meeting.
A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the agency’s Web site and call the FDA Advisory Committee Information Line to learn about possible modifications before coming to the meeting.
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 disabilities. If you require accommodations due to a disability, please contact Lauren Tesh at (301) 796-9001 at least 7 days in advance of the meeting.
Answers to commonly asked questions including information regarding special accommodations due to a disability may be accessed at: Common Questions and Answers about FDA Advisory Committee Meetings.
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Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app.2).