Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications, 31965-31966 [2011-13692]
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Federal Register / Vol. 76, No. 106 / Thursday, June 2, 2011 / Notices
Mr.
Eskinder Negash, Director, Office of
Refugee Resettlement, Administration
for Children and Families, 901 D Street,
SW., Washington, DC 20047. Telephone:
202–401–5388. E-mail:
Eskinder.Negash@acf.hhs.gov.
FOR FURTHER INFORMATION CONTACT:
Dated: May 25, 2011.
Eskinder Negash,
Director, Office of Refugee Resettlement.
[FR Doc. 2011–13677 Filed 6–1–11; 8:45 am]
BILLING CODE 4184–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA–2011–M–0034, FDA–
2011–M–0040, FDA–2011–M–0041, FDA–
2011–M–0039, FDA–2011–M–0035, FDA–
2011–M–0056, FDA–2011–M–0105, FDA–
2011–M–0131, FDA–2011–M–0132, FDA–
2011–M–0170, FDA–2011–M–0175, and
FDA–2011–M–0198]
Medical Devices; Availability of Safety
and Effectiveness Summaries for
Premarket Approval Applications
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
SUMMARY:
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 the Federal Register of January 30,
1998 (63 FR 4571), FDA published a
final rule that amended 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.
31965
In accordance with section 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 January 1, 2011, through
March 31, 2011. 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 JANUARY 1,
2011, THROUGH MARCH 31, 2011
PMA No.
Docket No.
Applicant
Trade name
Approval date
P010012 (S230) ....................
Boston Scientific Corp .........
BOSTON SCIENTIFIC CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATORS.
September 16, 2010.
FDA–2011–M–0034
P100021 ................................
Medtronic Vascular ..............
MEDTRONIC VASCULAR ENDURANT STENT GRAFT
SYSTEM.
December 16, 2010.
FDA–2011–M–0040
P100010 ................................
FDA–2011–M–0041
P070014 (S10) ......................
Medtronic Cryocath, LP .......
ARCTIC FRONT CRYOCATHETER SYSTEM .................
December 17, 2010.
Bard Peripheral Vascular ....
LIFESTENT AND LIFESTENT LX VASCULAR STENT
SYSTEMS.
December 23, 2010.
Depuy, Inc ...........................
CERAMAX CERAMIC HIP SYSTEM ................................
December 23, 2010.
Cook Medical, Inc ................
FORMULA BALLOON–EXPANDABLE RENAL STENT
SYSTEM.
January 14, 2011.
Medtronic, Inc ......................
REVO MRI SURESCAN IPG AND PACING SYSTEM .....
February 8, 2011.
Hologic, Inc ..........................
SELENIA DIMENSIONS 3D SYSTEMS ............................
February 11, 2011.
OraSure Technologies, Inc ..
ORAQUICK HCV RAPID ANTIBODY TEST .....................
February 18, 2011.
Elana, Inc .............................
ELANA SURGICAL KIT HUD ............................................
March 10, 2011.
Medtronic Neuromodulation
MEDTRONIC INTERSTIM THERAPY SYSTEM ...............
March 14, 2011.
emcdonald on DSK2BSOYB1PROD with NOTICES
FDA–2011–M–0039
P070026 ................................
FDA–2011–M–0035
P100028 ................................
FDA–2011–M–0056
P090013 ................................
FDA–2011–M–0105
P080003 ................................
FDA2011–M–0131
P080027 (S1) ........................
FDA–2011–M–0132
H080005 ...............................
FDA–2011–M–0170
P080025 ................................
FDA–2011–M–0175
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Federal Register / Vol. 76, No. 106 / Thursday, June 2, 2011 / Notices
TABLE 1—LIST OF SAFETY AND EFFECTIVENESS SUMMARIES FOR APPROVED PMAS MADE AVAILABLE FROM JANUARY 1,
2011, THROUGH MARCH 31, 2011—Continued
PMA No.
Docket No.
Applicant
Trade name
P80020 ..................................
FDA–2011–M–0198
Seikagaku Corp ...................
GEL–ONE ..........................................................................
II. Electronic Access
Persons with access to the Internet
may obtain the documents at https://
www.fda.gov/cdrh/pmapage.html.
Dated: May 27, 2011.
Nancy K. Stade,
Deputy Director for Policy Center for Devices
and Radiological Health.
[FR Doc. 2011–13692 Filed 6–1–11; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Notice of
Closed Meetings
emcdonald on DSK2BSOYB1PROD 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: Center for Scientific
Review Special Emphasis Panel, Member
Conflict: Neurodegenerative Cardiovascular
Disease and Imaging.
Date: June 16, 2011.
Time: 2 p.m. to 4 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Telephone Conference Call).
Contact Person: Suzan Nadi, PhD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5217B,
MSC 7846, Bethesda, MD 20892, 301–435–
1259, nadis@csr.nih.gov.
This notice is being published less than 15
days prior to the meeting due to the timing
limitations imposed by the review and
funding cycle.
Name of Committee: Center for Scientific
Review Special Emphasis Panel,
Neurodevelopment and Plasticity.
VerDate Mar<15>2010
18:17 Jun 01, 2011
Jkt 223001
Date: June 27, 2011.
Time: 1 p.m. to 4 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Telephone Conference Call).
Contact Person: Laurent Taupenot, PhD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4811,
MSC 7850, Bethesda, MD 20892, 301–435–
1203, taupenol@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel, Small
Business: AIDS/HIV Innovative Research
Applications.
Date: July 5, 2011.
Time: 8 a.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: The Allerton Hotel, 701 North
Michigan Avenue, Chicago, IL 60611.
Contact Person: Kenneth A Roebuck, PhD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5106,
MSC 7852, Bethesda, MD 20892, (301) 435–
1166, roebuckk@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel, Small
Business: Dermatology, Rheumatology and
Inflammation.
Date: July 5, 2011.
Time: 8:30 a.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: Bethesda North Marriott Hotel &
Conference Center, 5701 Marinelli Road,
Bethesda, MD 20852.
Contact Person: Aftab A Ansari, PhD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4108,
MSC 7814, Bethesda, MD 20892, 301–237–
9931, ansaria@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel, Gene
Regulation and Genomics.
Date: July 5, 2011.
Time: 10 a.m. to 2 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Telephone Conference Call).
Contact Person: Richard A Currie, PhD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 1108,
MSC 7890, Bethesda, MD 20892, (301) 435–
1219, currieri@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel,
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Approval date
March 22, 2011.
Fellowships: Neurodevelopment, Synaptic
Plasticity and Neurodegeneration.
Date: July 6–7, 2011.
Time: 8 a.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: Renaissance Washington, DC
Dupont Circle Hotel, 1143 New Hampshire
Avenue, NW., Washington, DC 20037.
Contact Person: Mary Schueler, PhD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5214,
MSC 7846, Bethesda, MD 20892, 301–451–
0996, marygs@mail.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel, Member
Conflict: Emphysema and Lung
Development.
Date: July 6–7, 2011.
Time: 9 a.m. to 6 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Virtual Meeting).
Contact Person: George M Barnas, PhD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4220,
MSC 7818, Bethesda, MD 20892, 301–435–
0696, barnasg@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel, Small
Business: Cardiovascular Sciences.
Date: July 7–8, 2011.
Time: 7:30 a.m. to 6 p.m.
Agenda: To review and evaluate grant
applications.
Place: InterContinental Chicago Hotel, 505
North Michigan Avenue, Chicago, IL 60611.
Contact Person: Lawrence E Boerboom,
PhD, Chief, CVRS IRG, Center for Scientific
Review, National Institutes of Health, 6701
Rockledge Drive, Room 4130, MSC 7814,
Bethesda, MD 20892, (301) 435–8367,
boerboom@nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel,
Fellowships: Behavioral Neuroscience.
Date: July 7–8, 2011.
Time: 8 a.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: Renaissance Washington, DC
Dupont Circle Hotel, 1143 New Hampshire
Avenue, NW., Washington, DC 20037.
Contact Person: Kristin Kramer, PhD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5205,
MSC 7846, Bethesda, MD 20892, (301) 437–
0911, kramerkm@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel, Small
E:\FR\FM\02JNN1.SGM
02JNN1
Agencies
[Federal Register Volume 76, Number 106 (Thursday, June 2, 2011)]
[Notices]
[Pages 31965-31966]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-13692]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA-2011-M-0034, FDA-2011-M-0040, FDA-2011-M-0041, FDA-
2011-M-0039, FDA-2011-M-0035, FDA-2011-M-0056, FDA-2011-M-0105, FDA-
2011-M-0131, FDA-2011-M-0132, FDA-2011-M-0170, FDA-2011-M-0175, and
FDA-2011-M-0198]
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 the Federal Register of January 30, 1998 (63 FR 4571), FDA
published a final rule that amended 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.
In accordance with section 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 January 1, 2011, through March 31,
2011. 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 January 1, 2011,
Through March 31, 2011
----------------------------------------------------------------------------------------------------------------
PMA No. Docket No. Applicant Trade name Approval date
----------------------------------------------------------------------------------------------------------------
P010012 (S230)................... Boston Scientific BOSTON SCIENTIFIC September 16, 2010.
Corp. CARDIAC
RESYNCHRONIZATION
THERAPY DEFIBRILLATORS.
FDA-2011-M-0034
P100021.......................... Medtronic Vascular. MEDTRONIC VASCULAR December 16, 2010.
ENDURANT STENT GRAFT
SYSTEM.
FDA-2011-M-0040
P100010.......................... Medtronic Cryocath, ARCTIC FRONT December 17, 2010.
LP. CRYOCATHETER SYSTEM.
FDA-2011-M-0041
P070014 (S10).................... Bard Peripheral LIFESTENT AND LIFESTENT December 23, 2010.
Vascular. LX VASCULAR STENT
SYSTEMS.
FDA-2011-M-0039
P070026.......................... Depuy, Inc......... CERAMAX CERAMIC HIP December 23, 2010.
SYSTEM.
FDA-2011-M-0035
P100028.......................... Cook Medical, Inc.. FORMULA BALLOON- January 14, 2011.
EXPANDABLE RENAL STENT
SYSTEM.
FDA-2011-M-0056
P090013.......................... Medtronic, Inc..... REVO MRI SURESCAN IPG February 8, 2011.
AND PACING SYSTEM.
FDA-2011-M-0105
P080003.......................... Hologic, Inc....... SELENIA DIMENSIONS 3D February 11, 2011.
SYSTEMS.
FDA2011-M-0131
P080027 (S1)..................... OraSure ORAQUICK HCV RAPID February 18, 2011.
Technologies, Inc. ANTIBODY TEST.
FDA-2011-M-0132
H080005.......................... Elana, Inc......... ELANA SURGICAL KIT HUD.. March 10, 2011.
FDA-2011-M-0170
P080025.......................... Medtronic MEDTRONIC INTERSTIM March 14, 2011.
Neuromodulation. THERAPY SYSTEM.
FDA-2011-M-0175
[[Page 31966]]
P80020........................... Seikagaku Corp..... GEL-ONE................. March 22, 2011.
FDA-2011-M-0198
----------------------------------------------------------------------------------------------------------------
II. Electronic Access
Persons with access to the Internet may obtain the documents at
https://www.fda.gov/cdrh/pmapage.html.
Dated: May 27, 2011.
Nancy K. Stade,
Deputy Director for Policy Center for Devices and Radiological Health.
[FR Doc. 2011-13692 Filed 6-1-11; 8:45 am]
BILLING CODE 4160-01-P