81 FR 489 - Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee; Amendment of Notice
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 3 (January 6, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 3 (January 6, 2016)
| Page Range | 489-489 | |
| FR Document | 2015-33262 |
[Federal Register Volume 81, Number 3 (Wednesday, January 6, 2016)] [Notices] [Page 489] From the Federal Register Online [www.thefederalregister.org] [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
![Federal Register / Vol. 81, No. 3 / Wednesday, January 6, 2016 / Notices 489
Agenda Dated: December 30, 2015. or without radicular pain) with current
Wade Hannum, episode lasting less than 1 year in
The purpose of the meeting is for the Office of Human Resources Management, duration secondary to lumbar
GLMRC to discuss the Council’s focus OHRM Director, Office of HR Strategy and degenerative disc disease (DDD) at a
for the upcoming year and consider Services, Center for Talent Engagement single symptomatic level from L2–L5.
Agency initiatives. The topics to be (COE4), General Services Administration. DDD is confirmed radiologically with
discussed include Council metrics & [FR Doc. 2015–33302 Filed 1–5–16; 8:45 am] one or more of the following factors: (1)
GSA EVS results, GSA EEO program, BILLING CODE 6820–34–P Patients must have greater than 2 mm of
and Council subcommittee updates. decreased disc height compared to the
adjacent level; (2) scarring/thickening of
Meeting Access
DEPARTMENT OF HEALTH AND the ligamentum flavum, annulus
The meeting is open to the public. HUMAN SERVICES fibrosis, or facet joint capsule; or (3)
The meeting will be held in Room 6044 herniated nucleus pulposus. The DIAM
Food and Drug Administration device is implanted via a minimally
of the General Services Administration’s
Headquarters Building, 1800 F Street [Docket No. FDA–2015–N–0001] invasive posterior approach.
NW., Washington, DC 20405. This site FDA intends to make background
Orthopaedic and Rehabilitation material available to the public no later
is accessible to individuals with
Devices Panel of the Medical Devices than 2 business days before the meeting.
disabilities. In order to gain entry into
Advisory Committee; Amendment of If FDA is unable to post the background
the Federal building where the meeting
Notice material on its Web site prior to the
is being held, public attendees who are meeting, the background material will
Federal employees should bring their AGENCY: Food and Drug Administration, be made publicly available at the
Federal employee identification cards, HHS. location of the advisory committee
and members of the general public ACTION: Notice. meeting, and the background material
should bring their driver’s license or will be posted on FDA’s Web site after
other government-issued identification. SUMMARY: The Food and Drug the meeting. Background material is
Administration (FDA) is announcing an available at http://www.fda.gov/
Availability of Materials for the amendment to the notice of meeting of
Meeting AdvisoryCommittees/Calendar/
the Orthopaedic and Rehabilitation default.htm. Scroll down to the
Devices Panel of the Medical Devices appropriate advisory committee meeting
Please see the GLRMC Web site:
Advisory Committee. This meeting was link.
http://www.gsa.gov/portal/content/
announced in the Federal Register of This notice is issued under the
225831 for any materials available in November 23, 2015. The amendment is
advance of the meeting and for meeting Federal Advisory Committee Act (5
being made to reflect a change in the U.S.C. app. 2) and 21 CFR part 14,
minutes that will be made available Agenda portion of the document. There
after the meeting. Detailed meeting relating to the advisory committees.
are no other changes.
minutes will be posted within 90 days Dated: December 30, 2015.
FOR FURTHER INFORMATION CONTACT: Sara
of the meeting. Anderson, Center for Devices and Leslie Kux,
Radiological Health, Food and Drug Associate Commissioner for Policy.
Procedures for Providing Public
Administration, Bldg. 66, Rm. 1643, [FR Doc. 2015–33262 Filed 1–5–16; 8:45 am]
Comments
10903 New Hampshire Ave., Silver BILLING CODE 4164–01–P
The public is invited to submit Spring, MD 20993,
written comments for the meeting until Sara.Anderson@fda.hhs.gov, 301–796–
5:00 p.m. Eastern Time on the Monday 7047, or FDA Advisory Committee DEPARTMENT OF HEALTH AND
prior to the meeting, by either of the Information Line, 1–800–741–8138 HUMAN SERVICES
following methods: (301–443–0572 in the Washington, DC
Food and Drug Administration
Electronic or Paper Statements: area). Please call the Information Line
Submit electronic statements to Ms. for up-to-date information on this [Docket No. FDA–2015–N–4952]
meeting.
Paula Lucak, Designated Federal Officer, Food and Drug Administration Safety
at paula.lucak@gsa.gov; or send paper SUPPLEMENTARY INFORMATION: In the
and Innovation Act 907 Public Meeting:
statements in triplicate to Ms. Lucak at Federal Register of November 23, 2015,
Progress on Enhancing the Collection,
1800 F Street NW., Suite 7003A, 80 FR 72971, FDA announced that a
Analysis, and Availability of
Washington, DC 20405. In general, meeting of the Orthopaedic and
Demographic Subgroup Data; Request
public comments will be posted on the Rehabilitation Devices Panel of the
for Comments
GLMRC Web site. All comments, Medical Devices Advisory Committee
including attachments and other would be held on February 19, 2016. On AGENCY: Food and Drug Administration,
supporting materials received, are part page 72972, in the first column, the HHS.
Agenda portion of the document is ACTION: Notice of public meeting;
of the public record and subject to
changed to read as follows: request for comments.
public disclosure.
The Committee will discuss, make
Any comments submitted in
mstockstill on DSK4VPTVN1PROD with NOTICES
recommendations, and vote on SUMMARY: The Food and Drug
connection with the GLMRC meeting information regarding the premarket Administration’s (FDA or Agency)
will be made available to the public application (PMA) for the DIAM Spinal Office of Minority Health (OMH), Office
under the provisions of the Federal Stabilization System, sponsored by of Women’s Health (OWH), the Center
Advisory Committee Act. Medtronic Sofamor Danek USA. The for Biologics Evaluation and Research
DIAM Spinal Stabilization System is (CBER), the Center for Drug Evaluation
indicated for skeletally mature patients and Research (CDER), and the Center for
that have moderate low back pain (with Devices and Radiological Health (CDRH)
VerDate Sep<11>2014 17:32 Jan 05, 2016 Jkt 238001 PO 00000 Frm 00031 Fmt 4703 Sfmt 4703 E:\FR\FM\06JAN1.SGM 06JAN1](https://thefederalregister.org/doc/81_FR_492/page/1.svg)
Document Created: 2016-01-06 04:02:11
Document Modified: 2016-01-06 04:02:11
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| 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. | |
| FR Citation | 81 FR 489 |
2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR