Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications, 53270-53271 [E9-24967]
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Federal Register / Vol. 74, No. 199 / Friday, October 16, 2009 / Notices
part 801 have been approved under
OMB control number 0910–0485.
V. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) written or electronic
comments regarding this document.
Submit a single copy of electronic
comments or two paper copies of any
mailed comments, except that
individuals may submit one paper copy.
Comments are to be identified with the
docket number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
Dated: October 2, 2009.
Jeffrey Shuren,
Acting Director, Center for Devices and
Radiological Health.
[FR Doc. E9–24964 Filed 10–15–09; 8:45 am]
BILLING CODE 4160–01–S
Food and Drug Administration
[Docket Nos. FDA–2009–M–0299, FDA–
2009–M–0300, FDA–2009–M–0182, FDA–
2009–M–0244, FDA–2009–M–0243, FDA–
2009–M–0255]
I. Background
Medical Devices; Availability of Safety
and Effectiveness Summaries for
Premarket Approval Applications
Food and Drug Administration,
HHS.
ACTION:
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, 301–796–6570.
SUPPLEMENTARY INFORMATION:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
AGENCY:
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.
Notice.
In the Federal Register of January 30,
1998 (63 FR 4571), FDA published a
final rule that revised 21 CFR 814.44(d)
and 814.45(d) to discontinue individual
publication of PMA approvals and
denials in the Federal Register. Instead,
the agency now posts this information
on the Internet on FDA’s home page at
https://www.fda.gov. FDA believes that
this procedure expedites public
notification of these actions because
announcements can be placed on the
Internet more quickly than they can be
published in the Federal Register, and
FDA believes that the Internet is
accessible to more people than the
Federal Register.
In accordance with section 515(d)(4)
and (e)(2) of the Federal Food, Drug, and
Cosmetic Act (the 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 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 April 1, 2009, through
June 30, 2009. 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,
2009, THROUGH JUNE 30, 2009.
PMA No./Docket No.
Applicant
TRADE NAME
Approval Date
Third Wave Technologies, Inc.
CERVISTA HPV HR
March 12, 2009
P080015
FDA–2009–M–0300
Third Wave Technologies, Inc.
CERVISTA HPV 16/18
March 12, 2009
P080006
FDA–2009–M–0182
Medtronic Inc.
MEDTRONIC ATTAIN ABILITY MODEL 4196 LEAD
April 7, 2009
P080023
FDA–2009–M–0244
jlentini on DSKJ8SOYB1PROD with NOTICES
P080014
FDA–2009–M–0299
Abbott Laboratories
ARCHITECT CORE REAGENT KIT, ARCHITECT
CORE CALIBRATOR AND ARCHITECT CORE
CONTROLS
April 10, 2009
P060023
FDA–2009–M–0243
Medtronic Sofamor Danek
BRYAN CERVICAL DISC
May 12, 2009
P060008 (S8)
FDA–2009–M–0255
Boston Scientific Co.
TAXUS LIBERTE ATOM PACLITAXEL–ELUTING
CORONARY STENT SYSTEM
May 21, 2009
VerDate Nov<24>2008
16:37 Oct 15, 2009
Jkt 220001
PO 00000
Frm 00058
Fmt 4703
Sfmt 4703
E:\FR\FM\16OCN1.SGM
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Federal Register / Vol. 74, No. 199 / Friday, October 16, 2009 / Notices
II. Electronic Access
Persons with access to the Internet
may obtain the documents at https://
www.fda.gov/cdrh/pmapage.html.
Dated: October 2, 2009.
Jeffrey Shuren,
Acting Director, Center for Devices and
Radiological Health.
[FR Doc. E9–24967 Filed 10–15–09; 8:45 am]
Research Support; 93.821, Cell Biology and
Biophysics Research; 93.859, Pharmacology,
Physiology, and Biological Chemistry
Research; 93.862, Genetics and
Developmental Biology Research; 93.88,
Minority Access to Research Careers; 93.96,
Special Minority Initiatives, National
Institutes of Health, HHS)
BILLING CODE 4160–01–S
Dated: October 7, 2009.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. E9–24704 Filed 10–15–09; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
BILLING CODE 4140–01–M
National Institutes of Health
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institute of General Medical
Sciences; Notice of Closed Meetings
jlentini on DSKJ8SOYB1PROD with NOTICES
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute of
General Medical Sciences Special Emphasis
Panel; NIGMS Knowledgebase Resource
Review.
Date: November 9, 2009.
Time: 1 p.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Natcher Building, Room 3AN18, 45 Center
Drive, Bethesda, MD 20892, (Telephone
Conference Call).
Contact Person: Brian R. Pike, PhD,
Scientific Review Officer, Office of Scientific
Review, National Institute of General Medical
Sciences, National Institutes of Health, 45
Center Drive, Room 3AN18, Bethesda, MD
20892, 301–594–3907, pikbr@mail.nih.gov.
Name of Committee: National Institute of
General Medical Sciences Special Emphasis
Panel; Minority Biomedical Research Score.
Date: November 16–17, 2009.
Time: 8 a.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: Palomar Hotel, 2121 P Street, NW.,
Washington, DC 20037.
Contact Person: Lisa Dunbar, PhD,
Scientific Review Officer, Office of Scientific
Review, National Institute of General Medical
Sciences, National Institutes of Health, 45
Center Drive, Room 3AN12, Bethesda, MD
20892, 301–594–2849, dunbarl@mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.375, Minority Biomedical
VerDate Nov<24>2008
16:37 Oct 15, 2009
Jkt 220001
National Institutes of Health
National Institute of General Medical
Sciences; Notice of Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute of
General Medical Sciences; Special Emphasis
Panel Minority Biomedical Research Score.
Date: November 9, 2009.
Time: 1 p.m. to 5:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Natcher Building, Room 3AN18, 45 Center
Drive, Bethesda, MD 20892. (Telephone
Conference Call).
Contact Person: Margaret J. Weidman, PhD,
Scientific Review Officer, Office of Scientific
Review, National Institute of General Medical
Sciences, National Institutes of Health, 45
Center Drive, Room 3ANI8B, Bethesda, MD
20892, 301–594–3663,
weidmanma@nigms.nih.gov.
Name of Committee: National Institute of
General Medical Sciences; Special Emphasis
Panel ZGM1 BRT–X (TR).
Date: November 13, 2009.
Time: 8 a.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: Hyatt Regency Hotel, One Bethesda
Metro Center, Bethesda, MD 20814.
Contact Person: John J. Laffan, PhD,
Scientific Review Officer, Office of Scientific
Review, National Institute of General Medical
Sciences, National Institutes of Health,
PO 00000
Frm 00059
Fmt 4703
Sfmt 4703
53271
Natcher Building, Room 3AN18J, Bethesda,
MD 20892, 301–594–2773.
Name of Committee: National Institute of
General Medical Sciences; Special Emphasis
Panel Minority Biomedical Research Score.
Date: November 16, 2009.
Time: 1 p.m. to 5:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Natcher Building, Room 3AN18, 45 Center
Drive, Bethesda, MD 20892. (Telephone
Conference Call).
Contact Person: Margaret J. Weidman, PhD,
Scientific Review Officer, Office of Scientific
Review, National Institute of General Medical
Sciences, National Institutes of Health, 45
Center Drive, Room 3AN18B, Bethesda, MD
20892, 301–594–3663,
weidmanma@nigms.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.375, Minority Biomedical
Research Support; 93.821, Cell Biology and
Biophysics Research; 93.859, Pharmacology,
Physiology, and Biological Chemistry
Research; 93.862, Genetics and
Developmental Biology Research; 93.88,
Minority Access to Research Careers; 93.96,
Special Minority Initiatives, National
Institutes of Health, HHS)
Dated: October 7, 2009.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. E9–24708 Filed 10–15–09; 8:45 am]
BILLING CODE 4140–01–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of General Medical
Sciences; Notice of Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute of
General Medical Sciences Initial Review
Group; Biomedical Research and Research
Training Review Subcommittee B.
Date: November 9, 2009.
Time: 8 a.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
E:\FR\FM\16OCN1.SGM
16OCN1
]]>Agencies
[Federal Register Volume 74, Number 199 (Friday, October 16, 2009)]
[Notices]
[Pages 53270-53271]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-24967]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA-2009-M-0299, FDA-2009-M-0300, FDA-2009-M-0182, FDA-
2009-M-0244, FDA-2009-M-0243, FDA-2009-M-0255]
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, 301-796-
6570.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of January 30, 1998 (63 FR 4571), FDA
published a final rule that revised 21 CFR 814.44(d) and 814.45(d) to
discontinue individual publication of PMA approvals and denials in the
Federal Register. Instead, the agency now posts this information on the
Internet on FDA's home page at https://www.fda.gov. FDA believes that
this procedure expedites public notification of these actions because
announcements can be placed on the Internet more quickly than they can
be published in the Federal Register, and FDA believes that the
Internet is accessible to more people than the Federal Register.
In accordance with section 515(d)(4) and (e)(2) of the Federal
Food, Drug, and Cosmetic Act (the 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 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 April 1, 2009, through June 30, 2009.
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, 2009, through June 30, 2009.
------------------------------------------------------------------------
PMA No./Docket Approval
No. Applicant TRADE NAME Date
------------------------------------------------------------------------
P080014 Third Wave CERVISTA HPV HR March 12,
FDA-2009-M-0299 Technologies, 2009
Inc.
------------------------------------------------------------------------
P080015 Third Wave CERVISTA HPV 16/18 March 12,
FDA-2009-M-0300 Technologies, 2009
Inc.
------------------------------------------------------------------------
P080006 Medtronic Inc. MEDTRONIC ATTAIN ABILITY April 7,
FDA-2009-M-0182 MODEL 4196 LEAD 2009
------------------------------------------------------------------------
P080023 Abbott ARCHITECT CORE REAGENT April 10,
FDA-2009-M-0244 Laboratories KIT, ARCHITECT CORE 2009
CALIBRATOR AND ARCHITECT
CORE CONTROLS
------------------------------------------------------------------------
P060023 Medtronic BRYAN CERVICAL DISC May 12,
FDA-2009-M-0243 Sofamor Danek 2009
------------------------------------------------------------------------
P060008 (S8) Boston TAXUS LIBERTE ATOM May 21,
FDA-2009-M-0255 Scientific Co. PACLITAXEL-ELUTING 2009
CORONARY STENT SYSTEM
------------------------------------------------------------------------
[[Page 53271]]
II. Electronic Access
Persons with access to the Internet may obtain the documents at
https://www.fda.gov/cdrh/pmapage.html.
Dated: October 2, 2009.
Jeffrey Shuren,
Acting Director, Center for Devices and Radiological Health.
[FR Doc. E9-24967 Filed 10-15-09; 8:45 am]
BILLING CODE 4160-01-S
