[Federal Register Volume 79, Number 165 (Tuesday, August 26, 2014)]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-20165]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-N-0001]
Circulatory System Devices Panel of the Medical Devices Advisory
Committee; Notice of Meeting
AGENCY: Food and Drug Administration, HHS.
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.
Name of Committee: Circulatory System 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 October 8, 2014, from 8
a.m. to 6 p.m. and on October 9, 2014, from 8 a.m. to 12:30 p.m.
Location: Hilton Washington DC North/Gaithersburg, Salons A, B, C,
and D, 620 Perry Pkwy., Gaithersburg, MD 20877. The hotel telephone
number is 301-977-8900.
Contact Person: Jamie Waterhouse, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 1611, Silver Spring, MD 20993-0002, 301-796-3063,
Jamie.Waterhouse@fda.hhs.gov, or FDA Advisory Committee Information
Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area). 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 at http://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the
appropriate advisory committee meeting link, or call the advisory
committee information line to learn about possible modifications before
coming to the meeting.
Agenda: On October 8, the committee will discuss, make
recommendations and vote on information related to the premarket
approval application regarding the Boston Scientific Corporation's
WATCHMAN Left Atrial Appendage (LAA) Closure Technology. FDA is seeking
committee review and recommendations regarding new clinical data and
associated additional adverse events including stroke that have become
available since the previous advisory committee meeting on the WATCHMAN
device, which was held December 11, 2013. The WATCHMAN LAA Closure
Technology is a percutaneously delivered permanent cardiac implant
placed in the left atrial appendage. This device is indicated to
prevent thromboembolism (TE) from the left atrial appendage. It may be
considered for use in patients with non-valvular atrial fibrillation
who are eligible for warfarin therapy to reduce the risk of stroke and
systemic embolism based on CHADS2 (congestive heart failure,
hypertension, age >75 years, diabetes, and prior stroke or transient
ischemic attack (TIA)) or CHA2DS2-VASc
(congestive heart failure, hypertension, age >75 years, diabetes
mellitus, stroke/TIA/TE, vascular disease, age 65-74, and sex category)
On October 9, the committee will discuss and make recommendations
regarding the classification of more-than-minimally manipulated
allograft heart valves (MMM Allograft HVs). A MMM Allograft HV is a
human valve or valved conduit that has been aseptically recovered from
qualified donors, dissected free from the human heart, and then
subjected to a manufacturing process(es) that alters the original
relevant characteristics of the tissue (21 CFR 1271.3(f), 21 CFR
1271.10(a)(1), and 21 CFR 1271.20). The valve is then stored until
needed by a recipient. An example of such a manufacturing process is
one that intentionally removes the cells and cellular debris with the
goal of reducing in vivo antigenicity.
MMM Allograft HVs are considered preamendment devices because they
were found substantially equivalent to devices in commercial
distribution prior to May 28, 1976, when the Medical Device Amendments
became effective. MMM Allograft HVs are currently regulated under
Product Code OHA, ``Heart Valve, More than Minimally Manipulated
Allograft,'' as unclassified devices and reviewed under the premarket
notification, 510(k), authority (21 CFR part 807). FDA is seeking
committee input on the safety and effectiveness of MMM Allograft HVs
and the regulatory classification for MMM Allograft HVs.
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
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 on or before
September 30, 2014. On October 8, oral presentations from the public
will be scheduled between approximately 1 p.m. and 2 p.m. On October 9,
oral presentations from the public will be scheduled between
approximately 9:45 a.m. and 10:15 a.m. Those individuals interested in
making formal oral presentations should notify the contact person 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 on or before September 22, 2014. Time allotted
for each presentation may be limited. If the number of registrants
requesting to speak is greater than can be reasonably accommodated
during the scheduled open public hearing session, FDA may conduct a
lottery to determine the speakers for the scheduled open public hearing
session. The contact person will notify interested persons regarding
their request to speak by September 24, 2014.
Persons attending FDA's advisory committee meetings are advised
that the Agency is not responsible for providing access to electrical
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 AnnMarie Williams,
Conference Management Staff, 301-796-5966,
Annmarie.Williams@fda.hhs.gov at least 7 days in advance of the
FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our Web site at http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures
on public conduct during advisory committee meetings.
Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).
Dated: August 20, 2014.
Associate Commissioner for Policy and Planning.
[FR Doc. 2014-20165 Filed 8-25-14; 8:45 am]
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