[Federal Register Volume 79, Number 165 (Tuesday, August 26, 2014)]
[Notices]
[Pages 50916-50917]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-20165]


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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.

ACTION: Notice.

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    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

[[Page 50917]]

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) 
scores.
    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 
link.
    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 
outlets.
    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 
meeting.
    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.
Peter Lurie,
Associate Commissioner for Policy and Planning.
[FR Doc. 2014-20165 Filed 8-25-14; 8:45 am]
BILLING CODE 4164-01-P