Document ID: FDA-2015-N-0001-0123
Agency: fda
Document Type: Notice
Title: Orthopaedic and Rehabilitation Devices Panel of the Medical Devices
Advisory Committee; Amendment of Notice
Posted Date: 2016-01-06T05:00Z

[Federal Register Volume 81, Number 3 (Wednesday, January 6, 2016)]
[Notices]
[Page 489]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-33262]

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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.

ACTION: Notice.

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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/Calendar/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.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-33262 Filed 1-5-16; 8:45 am]
 BILLING CODE 4164-01-P