Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications, 950-951 [2013-00004]
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950
Federal Register / Vol. 78, No. 4 / Monday, January 7, 2013 / Notices
The Director, Management Analysis
and Services Office has been delegated
the authority to sign Federal Register
notices pertaining to announcements of
meetings and other committee
management activities, for both the
Centers for Disease Control and
Prevention, and the Agency for Toxic
Substances and Disease Registry.
Dana Redford,
Acting Director, Management Analysis and
Services Office, Centers for Disease Control
and Prevention.
[FR Doc. 2013–00007 Filed 1–4–13; 8:45 am]
The Pre-Submission Program and
Meetings with FDA Staff’’ had been
submitted to the Office of Management
and Budget (OMB) for review and
clearance under the Paperwork
Reduction Act of 1995 and inviting the
public to submit comments on the
proposed study to OMB. As of the date
of this notice, FDA has not finalized the
policy document underlying this
information collection request. Thus,
FDA is withdrawing the proposed
collection of information published on
December 11, 2012, at this time.
Dated: December 31, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[FR Doc. 2013–00009 Filed 1–4–13; 8:45 am]
BILLING CODE 4160–01–P
Food and Drug Administration
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Docket No. FDA–2012–D–0530]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Guidance on
Medical Devices: The Pre-Submission
Program and Meetings With FDA Staff;
Withdrawal
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Food and Drug Administration
[Docket Nos. FDA–2012–M–0712, FDA–
2012–M–0713, FDA–2012–M–0734, FDA–
2012–M–0735, FDA–2012–M–0814, FDA–
2012–M–0833, FDA–2012–M–0893, FDA–
2012–M–0965, FDA–2012–M–0968, FDA–
2012–M–1011, and FDA–2012–M–1013]
Medical Devices; Availability of Safety
and Effectiveness Summaries for
Premarket Approval Applications
Withdrawal of notice.
This document withdraws a
Food and Drug Administration (FDA)
notice that published in the Federal
Register of December 11, 2012 (77 FR
73662).
SUMMARY:
This notice is withdrawn on
January 7, 2013.
FOR FURTHER INFORMATION CONTACT:
Daniel Gittleson, Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400B, Rockville, MD 20850, 301–796–
5156, Daniel.Gittleson@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: FDA
published a notice in the Federal
Register of December 11, 2012 (77 FR
73662), informing interested parties that
the proposed collection of information
entitled ‘‘Guidance on Medical Devices:
DATES:
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is publishing a
list of premarket approval applications
(PMAs) that have been approved. This
list is intended to inform the public of
the availability of safety and
effectiveness summaries of approved
PMAs through the Internet and the
Agency’s Division of Dockets
Management.
ADDRESSES: Submit written requests for
copies of summaries of safety and
effectiveness data to the Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
SUMMARY:
Lane, rm. 1061, Rockville, MD 20852.
Please cite the appropriate docket
number as listed in table 1 of this
document 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. 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 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 July 1, 2012, through
September 30, 2012. 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 JULY 1,
2012, THROUGH SEPTEMBER 30, 2012
wreier-aviles on DSK7SPTVN1PROD with
PMA No., Docket No.
Applicant
Trade name
P980022/S010, FDA–2012–
M–0965.
P000008/S017, FDA–2012–
M–1013.
P100049, FDA–2012–M–
0893.
P010031/S232, FDA–2012–
M–0814.
Medtronic MiniMed, Inc .....
Allergan, Inc ......................
Guardian Telemetered Glucose Monitoring System
(TGMS).
LAP–BAND TM Adjustable Gastric Banding System .....
February 16, 2011.
Torax Medical, Inc .............
LINX TM Reflux Management System ...........................
March 22, 2012.
Medtronic, Inc ....................
Concerto/Concerto II; Consulta; Maximo
Protecta/Protecta XT Families of CRT–Ds.
April 4, 2012.
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Approval date
II;
and
07JAN1
January 7, 2004.
951
Federal Register / Vol. 78, No. 4 / Monday, January 7, 2013 / Notices
TABLE 1—LIST OF SAFETY AND EFFECTIVENESS SUMMARIES FOR APPROVED PMAS MADE AVAILABLE FROM JULY 1,
2012, THROUGH SEPTEMBER 30, 2012—Continued
PMA No., Docket No.
Applicant
Trade name
P080030, FDA–2012–M–
0712.
P110007, FDA–2012–M–
0734.
P110037, FDA–2012–M–
0713.
P110030, FDA–2012–M–
0735.
P110043, FDA–2012–M–
0833.
P040024/S056, FDA–2012–
M–0968.
P110006, FDA–2012–M–
1011.
Glaukos Corp ....................
Glaukos iStent® Trabecular Micro-Bypass Stent and
Inserter.
Healon® EndoCoat OpViscosurgical Ophthalmic Device (OVD) (3% Sodium Hyaluronate).
COBAS® AmpliPrep/COBAS® TaqMan® CMV Test ....
June 25, 2012.
therascreen® KRAS RGQ PCR Kit ...............................
July 6, 2012.
Omnilink Elite Vascular Balloon-Expandable Stent
System.
Restylane L Injectable Gel ............................................
July 31, 2012.
Abbott Medical Optics, Inc
Roche Molecular Systems,
Inc.
QIAGEN Manchester, Ltd
Abbott Vascular .................
Medicis Aesthetics Holdings, Inc.
U-Systems, Inc ..................
II. Electronic Access
Dated: December 31, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–00004 Filed 1–4–13; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–1205]
Accessible Medical Device Labeling in
a Standard Content and Format Public
Workshop; Request for Comments
Food and Drug Administration,
HHS.
Notice of public workshop;
request for comments.
ACTION:
The Food and Drug
Administration (FDA) is announcing the
following public workshop entitled
‘‘Accessible Standardized Medical
Device Labeling.’’ The purpose of this
public workshop is to discuss the
growing need for medical device
labeling to be delivered in a clear,
concise, and readily accessible format so
that patients, caregivers, and healthcare
providers may access and utilize device
labeling as efficiently and effectively as
possible. This public workshop aims to
engage stakeholders in active discussion
with FDA and to encourage public
comments regarding standard content
and format for medical device labeling
and the use of a repository containing
medical device labeling.
wreier-aviles on DSK7SPTVN1PROD with
SUMMARY:
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Breast
Ultrasound
The public workshop will be
held on April 29, 2013, from 8 a.m. to
5 p.m. and April 30, 2013, from 8 a.m.
to 4 p.m.
ADDRESSES: The public workshop will
be held at the FDA White Oak Campus,
10903 New Hampshire Ave., Building
31 Conference Center, the Great Room
(rm. 1503A), Silver Spring, MD 20993.
Entrance for the public meeting
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.
FOR FURTHER INFORMATION CONTACT:
Mary Weick-Brady, Center for Devices
and Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, rm. 5426, 301–796–6089,
FAX: 301–847–8510, email:
Mary.Brady@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
Registration: Registration is free and
available on a first-come, first-served
basis. Persons interested in attending
this public workshop must register
online by April 5, 2013. Early
registration is recommended because
facilities are limited and, therefore, FDA
may limit the number of participants
from each organization. If time and
space permit, onsite registration on the
day of the public workshop will be
provided beginning at 7 a.m.
If you need special accommodations
due to a disability, please contact Joyce
Raines by email:
Joyce.Raines@fda.hhs.gov or phone:
301–796–5709 at least 7 days prior to
the public workshop.
To register for the public workshop,
please visit FDA’s Medical Devices
News & Events—Workshops &
DATES:
Persons with access to the Internet
may obtain the documents at https://
www.fda.gov/MedicalDevices/
ProductsandMedicalProcedures/
DeviceApprovalsandClearances/
PMAApprovals/default.htm.
AGENCY:
somo-v® Automated
(ABUS).
Approval date
PO 00000
Frm 00024
Fmt 4703
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System
July 2, 2012.
July 5, 2012.
August 30, 2012.
September 18, 2012
Conferences calendar at https://
www.fda.gov/MedicalDevices/
NewsEvents/WorkshopsConferences/
default.htm. Select this public
workshop from the posted events list.
Please provide complete contact
information for each attendee, including
name, title, affiliation, address, email,
and telephone number. Those without
Internet access should contact Mary
Weick-Brady to register (see FOR
FURTHER INFORMATION CONTACT).
Registrants will receive confirmation
after they have been accepted. You will
be notified if you are on a waiting list.
Streaming Webcast of the Public
Workshop: This public workshop will
also be Webcast. Persons interested in
viewing the Webcast must register
online by April 5, 2013, 5 p.m. EST.
Early registration is recommended
because Webcast connections are
limited. Organizations are requested to
register all participants, but to view
using one connection per location.
Webcast participants will be sent
technical system requirements after
registration and will be sent connection
access information after April 5, 2013. If
you have never attended a Connect Pro
event before, test your connection at
https://collaboration.fda.gov/common/
help/en/support/meeting_test.htm. To
get a quick overview of the Connect Pro
program, visit https://www.adobe.com/
go/connectpro_overview. FDA has
verified the Web site addresses in this
document, but FDA is not responsible
for any subsequent changes to the Web
sites after this document publishes in
the Federal Register.
Requests for Oral Presentations: This
public workshop includes a public
comment session and topic-focused
sessions. During online registration, you
may indicate if you wish to present
during a public comment session and
which topics you want to address. All
topic-focused sessions will be held
E:\FR\FM\07JAN1.SGM
07JAN1
]]>Agencies
[Federal Register Volume 78, Number 4 (Monday, January 7, 2013)]
[Notices]
[Pages 950-951]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-00004]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA-2012-M-0712, FDA-2012-M-0713, FDA-2012-M-0734, FDA-
2012-M-0735, FDA-2012-M-0814, FDA-2012-M-0833, FDA-2012-M-0893, FDA-
2012-M-0965, FDA-2012-M-0968, FDA-2012-M-1011, and FDA-2012-M-1013]
Medical Devices; Availability of Safety and Effectiveness
Summaries for Premarket Approval Applications
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is publishing a list of
premarket approval applications (PMAs) that have been approved. This
list is intended to inform the public of the availability of safety and
effectiveness summaries of approved PMAs through the Internet and the
Agency's Division of Dockets Management.
ADDRESSES: Submit written requests for copies of summaries of safety
and 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 of this document 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. The
30-day period for requesting reconsideration of an FDA action under
Sec. 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 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 July 1, 2012, through September 30,
2012. 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 July 1, 2012, Through
September 30, 2012
----------------------------------------------------------------------------------------------------------------
PMA No., Docket No. Applicant Trade name Approval date
----------------------------------------------------------------------------------------------------------------
P980022/S010, FDA-2012-M-0965.. Medtronic MiniMed, Guardian Telemetered January 7, 2004.
Inc. Glucose Monitoring
System (TGMS).
P000008/S017, FDA-2012-M-1013.. Allergan, Inc..... LAP-BAND \TM\ February 16, 2011.
Adjustable Gastric
Banding System.
P100049, FDA-2012-M-0893....... Torax Medical, Inc LINX \TM\ Reflux March 22, 2012.
Management System.
P010031/S232, FDA-2012-M-0814.. Medtronic, Inc.... Concerto/Concerto II; April 4, 2012.
Consulta; Maximo II;
and Protecta/Protecta
XT Families of CRT-Ds.
[[Page 951]]
P080030, FDA-2012-M-0712....... Glaukos Corp...... Glaukos iStent[supreg] June 25, 2012.
Trabecular Micro-
Bypass Stent and
Inserter.
P110007, FDA-2012-M-0734....... Abbott Medical Healon[supreg] July 2, 2012.
Optics, Inc. EndoCoat
OpViscosurgical
Ophthalmic Device
(OVD) (3% Sodium
Hyaluronate).
P110037, FDA-2012-M-0713....... Roche Molecular COBAS[supreg] July 5, 2012.
Systems, Inc. AmpliPrep/
COBAS[supreg]
TaqMan[supreg] CMV
Test.
P110030, FDA-2012-M-0735....... QIAGEN Manchester, therascreen[supreg] July 6, 2012.
Ltd. KRAS RGQ PCR Kit.
P110043, FDA-2012-M-0833....... Abbott Vascular... Omnilink Elite July 31, 2012.
Vascular Balloon-
Expandable Stent
System.
P040024/S056, FDA-2012-M-0968.. Medicis Aesthetics Restylane L Injectable August 30, 2012.
Holdings, Inc. Gel.
P110006, FDA-2012-M-1011....... U-Systems, Inc.... somo-v[supreg] September 18, 2012
Automated Breast
Ultrasound System
(ABUS).
----------------------------------------------------------------------------------------------------------------
II. Electronic Access
Persons with access to the Internet may obtain the documents at
https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/PMAApprovals/default.htm.
Dated: December 31, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-00004 Filed 1-4-13; 8:45 am]
BILLING CODE 4160-01-P
