[Federal Register Volume 77, Number 53 (Monday, March 19, 2012)]
[Notices]
[Pages 16038-16039]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-6484]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0001]


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

AGENCY: Food and Drug Administration, HHS.

[[Page 16039]]


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 April 25 and 26, 2012, 
from 8 a.m. to 6 p.m.
    Location: Holiday Inn, Ballroom, 2 Montgomery Village Ave., 
Gaithersburg, MD 20879. The hotel's phone number is 301-948-8900.
    Contact Person: Jamie Waterhouse, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Silver Spring, MD 20993, 301-796-3063, email: 
[email protected], or FDA Advisory Committee Information 
Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), and 
follow the prompts to the desired center or product 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 appropriate 
advisory committee hot line/phone line to learn about possible 
modifications before coming to the meeting.

Agenda

    On April 25, 2012, the committee will discuss, make recommendations 
and vote on information related to a supplement to the premarket 
approval application (PMA) for the HeartWare Ventricular Assist System 
(HVAS) sponsored by HeartWare, Inc. The HVAS is an implantable 
electrically powered centrifugal-flow rotary blood pump with external 
driver and power source(s). It is the first ventricular assist device 
that does not require the creation of an abdominal pump pocket. The 
HVAS is indicated for use as a bridge to cardiac transplantation in 
patients who are at risk of death from refractory, advanced heart 
failure.
    On April 26, 2012, the committee will discuss, make recommendations 
and vote on information related to the PMA for the Subcutaneous 
Implantable Cardioverter Defibrillator (S-ICD) System sponsored by 
Cameron Health, Inc. The S-ICD is the first implantable defibrillator 
that does not require the implantation of an electrode either on or in 
the heart. The S-ICD is intended to provide defibrillation therapy for 
the treatment of life-threatening ventricular tachyarrhythmias. The 
device is capable of delivering high energy defibrillation shocks as 
well as bradycardia demand mode cardiac pacing. The study provides data 
from the treatment of induced acute and chronic episodes of ventricular 
tachycardia/ventricular fibrillation and spontaneous episodes. In 
addition to the investigational device exemption study, clinical data 
were also obtained from using studies outside the United States and 
registries.
    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 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 17, 
2012. Oral presentations from the public will be scheduled between 
approximately 1 p.m. and 2 p.m. on April 25 and 26, 2012. 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 10, 2012. 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 12, 2012.
    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, 
at [email protected], 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 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: March 13, 2012.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2012-6484 Filed 3-16-12; 8:45 am]
BILLING CODE 4160-01-P