Ophthalmic Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting, 57941-57942 [2014-22905]

Download as PDF 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 http:// 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. VerDate Sep<11>2014 19:14 Sep 25, 2014 Jkt 232001 PO 00000 Frm 00073 Fmt 4703 Sfmt 4703 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. E:\FR\FM\26SEN1.SGM 26SEN1 mstockstill on DSK4VPTVN1PROD with NOTICES 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 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 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 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 November 10, 2014. Oral presentations from the public will be scheduled between approximately 1 VerDate Sep<11>2014 19:14 Sep 25, 2014 Jkt 232001 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 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). 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 http:// 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 26SEN1

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]


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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 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 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 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 
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 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).

    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