Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications, 17415-17416 [2013-06429]
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Federal Register / Vol. 78, No. 55 / Thursday, March 21, 2013 / Notices
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Dated: March 15, 2013.
Jill Hartzler Warner,
Acting Associate Commissioner for Special
Medical Programs.
[FR Doc. 2013–06415 Filed 3–20–13; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA–2012–M–1012, FDA–
2012–M–1039, FDA–2012–M–1048, FDA–
2012–M–1049, FDA–2012–M–1066, FDA–
2012–M–1084, FDA–2012–M–1085, FDA–
2012–M–1088, FDA–2012–M–1109, FDA–
2012–M–1110, FDA–2012–M–1111, FDA–
2012–M–1146, FDA–2012–M–1176, FDA–
2012–M–1183, and FDA–2012–M–1184]
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.
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17415
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.
ADDRESSES:
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 October 1, 2012, through
December 31, 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.
E:\FR\FM\21MRN1.SGM
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17416
Federal Register / Vol. 78, No. 55 / Thursday, March 21, 2013 / Notices
TABLE 1—LIST OF SAFETY AND EFFECTIVENESS SUMMARIES FOR APPROVED PMAS MADE AVAILABLE FROM OCTOBER 1,
2012, THROUGH DECEMBER 31, 2012
PMA No., Docket No.
Applicant
Trade name
P110038, FDA–2012–M–1012 ..............
Bolton Medical Inc ................................
P110042, FDA–2012–M–1048 ..............
Cameron Health, Inc ............................
P100003, FDA–2012–M–1039 ..............
Globus Medical, Inc .............................
Relay® Thoracic Stent-Graft with Plus
Delivery System.
Subcutaneous Implantable Defibrillator
(S–ICD®) System.
Secure-C Artificial Cervical Disc ..........
P120005, FDA–2012–M–1049 ..............
Dexcom, Inc .........................................
P120006, FDA–2012–M–1110 ..............
P120007, FDA–2012–M–1066 ..............
TriVascular, Inc ....................................
Gen-Probe, Inc .....................................
P110008, FDA–2012–M–1085 ..............
P110039, FDA–2012–M–1084 ..............
P110021, FDA–2012–M–1088 ..............
Paradigm Spine, LLC ...........................
InSightec, Inc .......................................
Edwards Lifesciences, LLC ..................
P100040/S008, FDA–2012–M–1109 .....
Medtronic Vascular ..............................
P100012, FDA–2012–M–1111 ..............
P120002, FDA–2012–M–1183 ..............
NuVasive, Inc .......................................
Cordis Corporation ...............................
P100022, FDA–2012–M–1146 ..............
Cook, Inc ..............................................
P100047, FDA–2012–M–1184 ..............
HeartWare, Inc .....................................
P120008, FDA–2012–M–1176 ..............
Abbott Laboratories ..............................
II. Electronic Access
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: March 15, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–06429 Filed 3–20–13; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities; Proposed Collection;
Comment Request
emcdonald on DSK67QTVN1PROD with NOTICES
ACTION:
Notice.
SUMMARY: In compliance with the
requirement for opportunity for public
comment on proposed data collection
projects (Section 3506(c)(2)(A) of Title
44, United States Code, as amended by
the Paperwork Reduction Act of 1995,
Pub. L. 104–13), the Health Resources
and Services Administration (HRSA)
publishes periodic summaries of
proposed projects being developed for
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15:09 Mar 20, 2013
Jkt 229001
Dexcom G4 PLATINUM Continuous
Glucose Monitoring System.
Ovation Abdominal Stent Graft System
APTIMA® HPV 16 18/45 Genotype
Assay.
coflex® Interlaminar Technology ..........
InSightec ExAblate® System ...............
Edwards SAPIENTM Transcatheter
Heart Valve.
Valiant® Thoracic Stent Graft with the
Captivia Delivery System.
PCM® Cervical Disc System ................
S.M.A.R.T.®
CONTROL®
and
S.M.A.R.T.® Vascular Stent Systems..
Zilver PTX Drug-Eluting Peripheral
Stent.
HeartWare® Ventricular Assist System
ARCHITECT AFP Assay, ARCHITECT
AFP Calibrators and ARCHITECT
AFP Controls.
submission to the Office of Management
and Budget (OMB) under the Paperwork
Reduction Act of 1995. To request more
information on the proposed project or
to obtain a copy of the data collection
plans and draft instruments, email
paperwork@hrsa.gov or call the HRSA
Reports Clearance Officer at (301) 443–
1984.
HRSA especially requests comments
on: (1) The necessity and utility of the
proposed information collection for the
proper performance of the agency’s
functions, (2) the accuracy of the
estimated burden, (3) ways to enhance
the quality, utility, and clarity of the
information to be collected, and (4) the
use of automated collection techniques
or other forms of information
technology to minimize the information
collection burden.
Information Collection Request Title:
Ryan White HIV/AIDS Treatment
Extension Act of 2009, Part A Minority
AIDS Initiative Report (the Part A MAI
Report): (OMB No. 0915–0304)—
EXTENSION
Abstract: HRSA’s HIV/AIDS Bureau
(HAB) administers the Ryan White HIV/
AIDS Part A Program authorized under
Title XXVI of the Public Health Service
Act (Ryan White HIV/AIDS Treatment
Extension Act of 2009). Part A provides
emergency relief for areas with
substantial need for HIV/AIDS care and
PO 00000
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Approval date
September 21,
2012.
September 28,
2012.
September 28,
2012.
October 5, 2012.
October 5, 2012.
October 12, 2012.
October 17, 2012.
October 18, 2012.
October 19, 2012.
October 26, 2012.
October 26, 2012.
November 7, 2012
November 14,
2012.
November 20,
2012.
November 28,
2012.
support services that are most severely
affected by the HIV/AIDS epidemic,
including eligible metropolitan areas
(EMAs) and Transitional Grant Areas
(TGAs). As a component of Part A, the
purpose of the Minority AIDS Initiative
(MAI) Supplement is to improve access
to high quality HIV care, services, and
outcomes for individuals in
disproportionately impacted
communities of color who are living
with HIV disease, including African
Americans, Latinos, Native Americans,
Asian Americans, Native Hawaiians,
and Pacific Islanders (Section
2693(b)(2)(A) of the Public Health
Service (PHS) Act). Since the purpose of
the Part A MAI is to expand access to
medical, health, and social support
services for disproportionately impacted
racial/ethnic minority populations
living with HIV/AIDS, it is important
that HRSA is able to report on
minorities served by the Part A MAI.
The Part A MAI Report is a data
collection instrument in which grantees
report on the number and characteristics
of clients served and services provided.
The Part A MAI Report, first approved
for use in March 2006, is designed to
collect performance data from Part A
grantees. The report has two parts: (1) A
web-based data entry application that
collects standardized quantitative and
qualitative information and (2) an
accompanying narrative report. Grantees
E:\FR\FM\21MRN1.SGM
21MRN1
]]>Agencies
[Federal Register Volume 78, Number 55 (Thursday, March 21, 2013)]
[Notices]
[Pages 17415-17416]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-06429]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA-2012-M-1012, FDA-2012-M-1039, FDA-2012-M-1048, FDA-
2012-M-1049, FDA-2012-M-1066, FDA-2012-M-1084, FDA-2012-M-1085, FDA-
2012-M-1088, FDA-2012-M-1109, FDA-2012-M-1110, FDA-2012-M-1111, FDA-
2012-M-1146, FDA-2012-M-1176, FDA-2012-M-1183, and FDA-2012-M-1184]
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 October 1, 2012, through December 31,
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.
[[Page 17416]]
Table 1--List of Safety and Effectiveness Summaries for Approved PMAs Made Available From October 1, 2012,
Through December 31, 2012
----------------------------------------------------------------------------------------------------------------
PMA No., Docket No. Applicant Trade name Approval date
----------------------------------------------------------------------------------------------------------------
P110038, FDA-2012-M-1012.......... Bolton Medical Inc... Relay[supreg] September 21, 2012.
Thoracic Stent-Graft
with Plus Delivery
System.
P110042, FDA-2012-M-1048.......... Cameron Health, Inc.. Subcutaneous September 28, 2012.
Implantable
Defibrillator (S-
ICD[supreg]) System.
P100003, FDA-2012-M-1039.......... Globus Medical, Inc.. Secure-C Artificial September 28, 2012.
Cervical Disc.
P120005, FDA-2012-M-1049.......... Dexcom, Inc.......... Dexcom G4 PLATINUM October 5, 2012.
Continuous Glucose
Monitoring System.
P120006, FDA-2012-M-1110.......... TriVascular, Inc..... Ovation Abdominal October 5, 2012.
Stent Graft System.
P120007, FDA-2012-M-1066.......... Gen-Probe, Inc....... APTIMA[supreg] HPV 16 October 12, 2012.
18/45 Genotype Assay.
P110008, FDA-2012-M-1085.......... Paradigm Spine, LLC.. coflex[supreg] October 17, 2012.
Interlaminar
Technology.
P110039, FDA-2012-M-1084.......... InSightec, Inc....... InSightec October 18, 2012.
ExAblate[supreg]
System.
P110021, FDA-2012-M-1088.......... Edwards Lifesciences, Edwards SAPIENTM October 19, 2012.
LLC. Transcatheter Heart
Valve.
P100040/S008, FDA-2012-M-1109..... Medtronic Vascular... Valiant[supreg] October 26, 2012.
Thoracic Stent Graft
with the Captivia
Delivery System.
P100012, FDA-2012-M-1111.......... NuVasive, Inc........ PCM[supreg] Cervical October 26, 2012.
Disc System.
P120002, FDA-2012-M-1183.......... Cordis Corporation... S.M.A.R.T.[supreg] November 7, 2012
CONTROL[supreg] and
S.M.A.R.T.[supreg]
Vascular Stent
Systems..
P100022, FDA-2012-M-1146.......... Cook, Inc............ Zilver PTX Drug- November 14, 2012.
Eluting Peripheral
Stent.
P100047, FDA-2012-M-1184.......... HeartWare, Inc....... HeartWare[supreg] November 20, 2012.
Ventricular Assist
System.
P120008, FDA-2012-M-1176.......... Abbott Laboratories.. ARCHITECT AFP Assay, November 28, 2012.
ARCHITECT AFP
Calibrators and
ARCHITECT AFP
Controls.
----------------------------------------------------------------------------------------------------------------
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: March 15, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-06429 Filed 3-20-13; 8:45 am]
BILLING CODE 4160-01-P
