Ophthalmic Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting, 57941-57942 [2014-22905]
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Federal Register / Vol. 79, No. 187 / Friday, September 26, 2014 / Notices
effectiveness data to the Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
Please cite the appropriate docket
number as listed in table 1 when
submitting a written request. See the
SUPPLEMENTARY INFORMATION section for
electronic access to the summaries of
safety and effectiveness.
FOR FURTHER INFORMATION CONTACT:
Nicole Wolanski, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 1650, Silver Spring,
MD 20993–0002, 301–796–6570.
SUPPLEMENTARY INFORMATION:
I. Background
In accordance with sections 515(d)(4)
and (e)(2) of the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) (21 U.S.C.
360e(d)(4) and (e)(2)), notification of an
order approving, denying, or
withdrawing approval of a PMA will
continue to include a notice of
opportunity to request review of the
order under section 515(g) of the FD&C
Act (21 U.S.C. 360e(g)). The 30-day
period for requesting reconsideration of
an FDA action under § 10.33(b) (21 CFR
10.33(b)) for notices announcing
approval of a PMA begins on the day the
notice is placed on the Internet. Section
10.33(b) provides that FDA may, for
good cause, extend this 30-day period.
Reconsideration of a denial or
57941
withdrawal of approval of a PMA may
be sought only by the applicant; in these
cases, the 30-day period will begin
when the applicant is notified by FDA
in writing of its decision.
The regulations provide that FDA
publish a quarterly list of available
safety and effectiveness summaries of
PMA approvals and denials that were
announced during that quarter. The
following is a list of approved PMAs for
which summaries of safety and
effectiveness were placed on the
Internet from April 1, 2014, through
June 30, 2014. There were no denial
actions during this period. The list
provides the manufacturer’s name, the
product’s generic name or the trade
name, and the approval date.
TABLE 1—LIST OF SAFETY AND EFFECTIVENESS SUMMARIES FOR APPROVED PMAS MADE AVAILABLE FROM APRIL 1,
2014, THROUGH JUNE 30, 2014
PMA No., Docket No.
Applicant
Trade name
P130016, FDA–2014–
M–0327.
P120020, FDA–2014–
M–0434.
P010015/S205, FDA–
2014–M–0553.
P010031/S381, FDA–
2014–M–0553.
P100020/S008, FDA–
2014–M–0552.
P130008, FDA–2014–
M–0690.
P110005, FDA–2014–
M–0691.
P110041, FDA–2014–
M–0692.
Cochlear Americas ..............................
Nucleus® HybridTM L24 Cochlear Implant System ...........
March 20, 2014.
Abbott Vascular (IDEV Technologies,
Inc.).
Medtronic, Inc .....................................
SUPERA® Peripheral Stent System ..................................
March 28, 2014.
April 10, 2014.
Roche Molecular Systems, Inc ...........
Cardiac Resynchronization Therapy Pacemaker (CRT–P)
Devices.
Cardiac Resynchronization Therapy Defibrillator (CRT–D)
Devices.
cobas® HPV Test ..............................................................
April 24, 2014.
Inspire Medical Systems, Inc ..............
Inspire Upper Airway Stimulation (UAS) system ...............
April 30, 2014.
IBSA Institut Biochimique SA .............
Gel-SynTM Sinovial (Sodium Hyaluronate 0.8%) ..............
May 9, 2014.
Siemens Healthcare Diagnostics ........
May 16, 2014.
P110027, FDA–2014–
M–0726.
P100045, FDA–2014–
M–0727.
P130027, FDA–2014–
M–0866.
P040024/S072, FDA–
2014–M–0872.
QIAGEN Manchester Ltd ....................
ADVIA Centaur® HBsAgII, ADVIA Centaur® HBsAg Confirmatory and ADVIA Centaur® HBsAg Quality Control
Material.
therascreen® KRAS RGQ PCR Kit ...................................
CardioMEMS, Inc ................................
CardioMEMSTM HF System ..............................................
May 28, 2014.
QIAGEN, Inc .......................................
artus® CMV RGQ MDx Kit ................................................
June 2, 2014.
Valeant Pharmaceuticals North America LLC/Medicis.
Restylane Silk Injectable Gel .............................................
June 13, 2014.
Medtronic, Inc .....................................
II. Electronic Access
mstockstill on DSK4VPTVN1PROD with NOTICES
Persons with access to the Internet
may obtain the documents at https://
www.fda.gov/MedicalDevices/Products
andMedicalProcedures/Device
ApprovalsandClearances/PMA
Approvals/default.htm.
Dated: September 23, 2014
Leslie Kux,
Assistant Commissioner for Policy.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–0001]
Ophthalmic Devices Panel of the
Medical Devices Advisory Committee;
Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
Notice.
[FR Doc. 2014–22987 Filed 9–25–14; 8:45 am]
ACTION:
BILLING CODE 4164–01–P
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.
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Approval date
April 10, 2014.
May 23, 2014.
Name of Committee: Ophthalmic
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 November 14, 2014, from 8 a.m.
to 6 p.m.
Location: Hilton Washington, DC
North/Gaithersburg, Montgomery
Ballroom, 620 Perry Pkwy.,
Gaithersburg, MD 20877. The hotel’s
telephone number is 301–977–8900.
Contact Person: Natasha Facey, Center
for Devices and Radiological Health,
Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 66, Rm.
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57942
Federal Register / Vol. 79, No. 187 / Friday, September 26, 2014 / Notices
1552, Silver Spring, MD 20993, 301–
796–5290, Natasha.Facey@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 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.
Agenda: On November 14, 2014, the
committee will discuss, make
recommendations, and vote on
information related to the premarket
approval application for the AcrySof®
IQ ReSTOR® Multifocal Toric Posterior
Chamber Intraocular Lens submitted by
applicant Alcon Laboratories, Inc. This
intraocular lens combines the optical
properties of a +3 diopter multifocal
intraocular lens with the optical
properties of a toric intraocular lens.
The proposed indication for use is: The
AcrySof® IQ ReSTOR® Multifocal Toric
Posterior Chamber Intraocular Lens
(IOL) are intended for primary
implantation for the visual correction of
aphakia and pre-existing astigmatism
secondary to removal of a cataractous
lens in adult patients with and without
presbyopia, who desire near,
intermediate and distance vision,
reduction of residual refractive cylinder,
and increased spectacle independence.
The lens is intended to be placed in the
capsular bag.
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 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 November 10, 2014.
Oral presentations from the public will
be scheduled between approximately 1
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19:14 Sep 25, 2014
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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 October
30, 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 November 3, 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 James Clark
at James.Clark@fda.hhs.gov or 301–796–
5293 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
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).
Date: September 22, 2014.
Jill Hartzler Warner,
Associate Commissioner for Special Medical
Programs.
[FR Doc. 2014–22905 Filed 9–25–14; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–1413]
Patient-Focused Drug Development
Public Meeting and Scientific
Workshop on Female Sexual
Dysfunction
AGENCY:
Food and Drug Administration,
HHS.
PO 00000
Frm 00074
Fmt 4703
Sfmt 4703
Notice of public meeting and
workshop; request for comments.
ACTION:
The Food and Drug
Administration (FDA) is announcing a
public meeting and scientific workshop,
both of which will provide an
opportunity for public comment on the
topic of Female Sexual Interest/Arousal
Disorder (FSIAD), the most common
form of female sexual dysfunction.
FSIAD is a diagnosis that combines two
previously distinct disorders—
hypoactive sexual desire disorder
(HSDD) and female sexual arousal
disorder (FSAD). The public meeting
will take place on October 27, 2014, and
is part of FDA’s Patient-Focused Drug
Development performance
commitments made as part of the fifth
authorization of the Prescription Drug
User Fee Act (PDUFA V). At this
meeting, FDA will obtain patients’
perspectives on the impact that FSIAD
(or a prior diagnosis of HSDD or FSAD)
has on their daily lives, as well as their
perspectives on the available therapies
for these conditions. The scientific
workshop will take place on October 28,
2014, and will provide an opportunity
for FDA to seek input from experts on
scientific issues important to the
clinical development of drug products
intended to treat FSIAD.
DATES: The meeting will be held on
October 27, 2014, from 12 p.m. to 5 p.m.
and the workshop will be held on
October 28, 2014, from 8 a.m. to 5 p.m.
Registration to attend either the meeting
or the workshop must be received by
October 17, 2014. See the
SUPPLEMENTARY INFORMATION section for
information on how to register for either
the meeting or the workshop. Submit
electronic or written comments by
December 29, 2014.
ADDRESSES: The meeting and workshop
will be held at the FDA White Oak
Campus, 10903 New Hampshire Ave.,
Bldg. 31 Conference Center, Sections B/
C of the Great Room (rm. 1503), Silver
Spring, MD 20993. Entrance for the
public meeting and workshop
participants (non-FDA employees) is
through Building 1 where routine
security check procedures will be
performed. For parking and security
information, please refer to https://
www.fda.gov/AboutFDA/
WorkingatFDA/BuildingsandFacilities/
WhiteOakCampusInformation/
ucm241740.htm.
Submit electronic comments to
www.regulations.gov. Submit written
comments to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane,
Room 1061, Rockville, MD 20852. All
comments should be identified with the
SUMMARY:
E:\FR\FM\26SEN1.SGM
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]]>Agencies
[Federal Register Volume 79, Number 187 (Friday, September 26, 2014)]
[Notices]
[Pages 57941-57942]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-22905]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-N-0001]
Ophthalmic Devices Panel of the Medical Devices Advisory
Committee; Notice of Meeting
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
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: Ophthalmic 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 November 14, 2014, from
8 a.m. to 6 p.m.
Location: Hilton Washington, DC North/Gaithersburg, Montgomery
Ballroom, 620 Perry Pkwy., Gaithersburg, MD 20877. The hotel's
telephone number is 301-977-8900.
Contact Person: Natasha Facey, Center for Devices and Radiological
Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
66, Rm.
[[Page 57942]]
1552, Silver Spring, MD 20993, 301-796-5290, Natasha.Facey@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 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.
Agenda: On November 14, 2014, the committee will discuss, make
recommendations, and vote on information related to the premarket
approval application for the AcrySof[supreg] IQ ReSTOR[supreg]
Multifocal Toric Posterior Chamber Intraocular Lens submitted by
applicant Alcon Laboratories, Inc. This intraocular lens combines the
optical properties of a +3 diopter multifocal intraocular lens with the
optical properties of a toric intraocular lens. The proposed indication
for use is: The AcrySof[supreg] IQ ReSTOR[supreg] Multifocal Toric
Posterior Chamber Intraocular Lens (IOL) are intended for primary
implantation for the visual correction of aphakia and pre-existing
astigmatism secondary to removal of a cataractous lens in adult
patients with and without presbyopia, who desire near, intermediate and
distance vision, reduction of residual refractive cylinder, and
increased spectacle independence. The lens is intended to be placed in
the capsular bag.
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 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
November 10, 2014. Oral presentations from the public will be scheduled
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 October 30, 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 November 3, 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 James Clark at
James.Clark@fda.hhs.gov or 301-796-5293 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 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).
Date: September 22, 2014.
Jill Hartzler Warner,
Associate Commissioner for Special Medical Programs.
[FR Doc. 2014-22905 Filed 9-25-14; 8:45 am]
BILLING CODE 4164-01-P
