[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]
=======================================================================
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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,
[email protected], 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