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  4. June 19-20, 2019: Circulatory System Devices Panel of the Medical Devices Advisory Committee Meeting Announcement - 06/19/2019 - 06/20/2019
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Advisory Committee Meeting

Event Title
June 19-20, 2019: Circulatory System Devices Panel of the Medical Devices Advisory Committee Meeting Announcement
June 19-20, 2019

Date:
June 19-20, 2019
Time:
08:00 AM - 03:00 PM EDT

Center Date Time Location
CDRH June 19, 2019
June 20, 2019
8:00 a.m. - 5:00 p.m.
8:00 a.m. - 3:00 p.m.
Gaithersburg Holiday Inn
Grand Ballroom
Two Montgomery Village Ave.
Gaithersburg, MD 20879
301–948–8900

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-1677]

Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

SUMMARY:  The Food and Drug Administration (FDA) 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 June 19, 2019, from 8 a.m. to 5 p.m., and June 20, 2019, from 8 a.m. to 3 p.m.

ADDRESSES:  Gaithersburg Holiday Inn, Grand Ballroom, Two Montgomery Village Ave., Gaithersburg, MD  20879.  The hotel's telephone number is 301-948-8900; additional information is available online at:  https://www.ihg.com/holidayinn/hotels/us/en/gaithersburg/wasrv/hoteldetail?cm_mmc=Google.  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:  Evella Washington, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. G640, Silver Spring, MD  20993-0002, Evella.Washington@fda.hhs.gov, 301-796-6683, 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.

SUPPLEMENTARY INFORMATION:

Agenda:  On June 19 and 20, 2019, the committee will discuss and make recommendations on information related to recent observations of increased long-term mortality in peripheral arterial disease patients treated with paclitaxel-coated balloons and paclitaxel-eluting stents compared to patients treated with uncoated comparator devices.  FDA requests panel input regarding the presence and magnitude of the signal and potential causes.  FDA also seeks input regarding appropriate regulatory actions associated with the findings.

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 (see FOR FURTHER INFORMATION CONTACT) on or before May 22, 2019.  Oral presentations from the public will be scheduled on June 19, 2019, between approximately 1 p.m. and 2 p.m.; and on June 20, 2019, between approximately 10:30 a.m. and 11:30 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 May 14, 2019.  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 May 15, 2019.

Representatives from industry, professional organizations, and societies interested in making formal presentations to the committee should notify the contact person on or before May 22, 2019.

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 Artair Mallett at Artair.Mallett@fda.hhs.gov or 301-796-9638 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:  April 17, 2019.

Lowell J. Schiller,

Principal Associate Commissioner for Policy.
 


Meeting Materials

Title File Type/Size Source Organization
Circulatory System Devices Panel June 19, 2019 Agenda pdf (159.86 KB)
Circulatory System Devices Panel June 20, 2019 Agenda pdf (129.94 KB)
Circulatory System Devices Panel June 19, 2019 Bibliography pdf (40.38 KB)
Circulatory System Devices Panel June 19, 2019 FDA Executive Summary pdf (2.07 MB)
Circulatory System Devices Panel June 19, 2019 Appendix K (Cook Medical) pdf (733.02 KB)
Circulatory System Devices Panel June 19, 2019 Appendix L (BD BARD Lutonix) pdf (937.45 KB)
Circulatory System Devices Panel June 19, 2019 Appendix M (Medtronic) pdf (781.24 KB)
Circulatory System Devices Panel June 19, 2019 Appendix N (Spectranetics) pdf (285.71 KB)
Circulatory System Devices Panel June 19, 2019 Appendix O (Boston Scientific) pdf (671.9 KB)
Circulatory System Devices Panel June 19, 2019 Webcast Link pdf (21.01 KB)
Circulatory System Devices Panel June 20, 2019 Webcast Link pdf (21.01 KB)
Circulatory System Devices Panel June 19, 2019 Roster pdf (57.47 KB)
Circulatory System Devices Panel June 20, 2019 Roster pdf (56.23 KB)
Circulatory System Devices Panel June 19, 2019 Panel Questions pdf (103.7 KB)
Circulatory System Devices Panel June 20, 2019 Panel Questions pdf (94.11 KB)
Circulatory System Devices Panel June 19, 2019 Presentation (FDA) pdf (1.42 MB)
Circulatory System Devices Panel June 19, 2019 Presentation (Cook Medical) pdf (670.44 KB)
Circulatory System Devices Panel June 19, 2019 Presentation (Bard Lutonix) pdf (468.07 KB)
Circulatory System Devices Panel June 19, 2019 Presentation (Phillips) pdf (836.62 KB)
Circulatory System Devices Panel June 19, 2019 Presentation (Boston Scientific) pdf (1.45 MB)
Circulatory System Devices Panel June 19, 2019 Presentation (Pan Industry) pdf (161.47 KB)
Circulatory System Devices Panel June 19-20, 2019 24 Hour Summary pdf (71.84 KB)
Circulatory System Devices Panel June 19, 2019 FDA Trial Differences pdf (162.49 KB)
Circulatory System Devices Panel June 19, 2019 FDA Presentation - Audrey pdf (197.42 KB)
Circulatory System Devices Panel June 20, 2019 Action Items pdf (58.29 KB)
Circulatory System Devices Panel June 20, 2019 FDA Presentation - Audrey pdf (159.92 KB)
Circulatory System Surgery Devices Panel June 20, 2019 FDA Presentation pdf (574.66 KB)
Circulatory System Surgery Devices Panel June 20, 2019 FDA Questions pdf (312.45 KB)
Circulatory System Surgery Devices Panel June 20, 2019 Combined Industry Presentation pdf (1.39 MB)
Circulatory System Surgery Devices Panel June 20, 2019 Bard Presentation pdf (92.89 KB)
Circulatory System Surgery Devices Panel June 19-20, 2019 Medtronic Presentation pdf (1.19 MB)
Circulatory System Surgery Devices Panel June 20, 2019 Boston Scientific Presentation pdf (563.41 KB)
Circulatory System Devices Panel June 19, 2019 Transcript pdf (1.92 MB)
Circulatory System Devices Panel June 20, 2019 Transcript pdf (1.5 MB)

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.

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 and call the FDA Advisory Committee Information Line to learn about possible modifications before coming to the meeting.

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 Lauren Tesh at (301) 796-9001 at least 7 days in advance of the meeting.

Answers to commonly asked questions including information regarding special accommodations due to a disability may be accessed at: Common Questions and Answers about FDA Advisory Committee Meetings.

FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at Public Conduct During FDA Advisory Committee Meetings 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).