Document ID: FDA-2020-N-0008-0010
Agency: fda
Document Type: Notice
Title: Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting
Posted Date: 2020-03-13T04:00Z

[Federal Register Volume 85, Number 50 (Friday, March 13, 2020)]
[Notices]
[Pages 14681-14682]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-05132]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-N-0008]

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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SUMMARY: The Food and Drug Administration (FDA or Agency) announces a 
forthcoming public advisory committee meeting of the Circulatory System 
Devices Panel of the Medical Devices Advisory Committee. The general 
function of the committee is to provide advice and recommendations to 
the Agency on FDA's regulatory issues. The meeting will be open to the 
public.

DATES: The meeting will be held on April 16, 2020, from 8 a.m. to 6 
p.m.

ADDRESSES: Doubletree by Hilton Washington, DC North/Gaithersburg, 
Salons A, B, C, and D, 620 Perry Pkwy., Gaithersburg, MD 20877. The 
hotel's telephone number is 301-977-8900. The hotel's website is at: 
https://doubletree3.hilton.com/en/hotels/maryland/doubletree-by-hilton-washington-dc-north-gaithersburg-GAIGWDT/index.html. Answers to 
commonly asked questions including information regarding special 
accommodations due to a disability, visitor parking, and transportation 
may be accessed at: https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm.

FOR FURTHER INFORMATION CONTACT: Aden Asefa, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 5214, Silver Spring, MD 20993-0002, 
Aden.Asefa@fda.hhs.gov, 301-796-0400, 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 website at https://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.

[[Page 14682]]

SUPPLEMENTARY INFORMATION:
    Agenda: On April 16, 2020, the committee will discuss, make 
recommendations, and vote on information regarding the premarket 
approval application (PMA) for the TransMedics Organ Care System 
(OCS)--Heart, by TransMedics, Inc. The proposed Indication for Use for 
the TransMedics OCS--Heart, as stated in the PMA, is as follows:
    The TransMedics Organ Care System (OCS) Heart System is a portable 
ex-vivo organ perfusion and monitoring system indicated for the 
resuscitation, preservation, and assessment of donor hearts with one or 
more of the following characteristics for transplantation into a 
potential recipient in a near-physiologic, normothermic, and beating 
state:

 Expected cross-clamp or ischemic time >=4 hours due to donor 
or recipient characteristics (e.g., donor- recipient geographical 
distance, expected recipient surgical time)
 Donor age >=55 years
 Donors with history cardiac arrest and downtime >=20 minutes
 Donor history of alcohol use
 Donor LV ejection fraction (LVEF) <=50% but >=40%
 Donor history of left ventricular hypertrophy (septal or 
posterior wall thickness of >12 <=16 mm)

    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 website 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 website after the meeting. Background material is 
available at https://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 
April 9, 2020. Oral presentations from the public will be scheduled on 
April 16, 2020, between approximately 1 p.m. and 2 p.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 
April 1, 2020. 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 April 2, 2020.
    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 
disabilities. If you require accommodations due to a disability, please 
contact AnnMarie Williams at Annmarie.Williams@fda.hhs.gov or 301-796-
5966 at least 7 days in advance of the meeting.
    FDA is committed to the orderly conduct of its advisory committee 
meetings. Please visit our website at https://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: March 9, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-05132 Filed 3-12-20; 8:45 am]
 BILLING CODE 4164-01-P