Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications, 13855-13856 [E6-3850]
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Federal Register / Vol. 71, No. 52 / Friday, March 17, 2006 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. 2005M–0435, 2005M–0475,
2005M–0473, 2005M–0478, 2005M–0454,
2005M–0399, 2005M–0477, 2005M–0476,
2005M–0492, 2005M–0474, 2005M–0504]
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.
Submit written requests for
copies of summaries of safety and
effectiveness 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
ADDRESSES:
PMA No./Docket No.
submitting a written request. See the
section for
electronic access to the summaries of
safety and effectiveness.
FOR FURTHER INFORMATION CONTACT:
Thinh Nguyen, Center for Devices and
Radiological Health (HFZ–402), Food
and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850,
301–594–2186 ext. 152.
SUPPLEMENTARY INFORMATION:
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
Applicant
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 October 1, 2005 through
December 31, 2005. 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 October 1,
2005 through December 31, 2005
Trade Name
Approval Date
Guidant CRM Corp.
VENTAK PRIZM AVT AICD SYSTEM
March 27, 2003
P020045/2005M–0475
CryoCath Technologies, Inc.
7F FREEZOR CARDIAC
CRYOBLATION CATHETER &
CCT.2 CRYOCONSOLE SYSTEM
April 17, 2003
P040003/2005M–0473
InSightec—North America
EXABLATE 2000 SYSTEM
October 22, 2004
P030056/2005M–0478
Bayer Healthcare, LLC
ADVIA CENTAUR HCV READY
PACK REAGENTS, ADVIA
CENTAUR HCV QUALITY
CONTROL MATERIALS
December 22, 2004
P980022(S11)/2005M–0454
Medtronic MiniMed
GUARDIAN RT CONTINUOUS
GLUCOSE MONITORING
SYSTEM
July 18, 2005
P020016/2005M–0399
Walter Lorenz Surgical, Inc.
TOTAL TEMPOMANDIBULAR
JOINT REPLACEMENT SYSTEM
September 21, 2005
P040047/2005M–0477
Bioform Medical, Inc.
COAPTITE
November 10, 2005
P040042/2005M–0476
sroberts on PROD1PC70 with NOTICES
P960040(S28)/2005M–0435
Irvine Biomedical, Inc.
THERAPY DUAL 8 CARDIAC
ABLATION SYSTEM
November 18, 2005
P030054(S10)/2005M–0492
St. Jude Medical CRMD
EPIC & ATLAS + HF CRT–D
SYSTEMS
November 18, 2005
P040013/2005M–0474
Biomimetic Therapeutics, Inc.
GEM 21S (GROWTH-FACTOR
ENHANCED MATRIX)
November 18, 2005
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13856
Federal Register / Vol. 71, No. 52 / Friday, March 17, 2006 / Notices
PMA No./Docket No.
Applicant
P040045/2005M–0504
Vistakon, Division of Johnson &
Johnson Vision Care, Inc.
II. Electronic Access
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Manufacturing Subcommittee of the
Advisory Committee for
Pharmaceutical Science; Cancellation
Food and Drug Administration,
HHS.
Notice.
The Food and Drug
Administration (FDA) is canceling the
meeting of the Manufacturing
Subcommittee of the Advisory
Committee for Pharmaceutical Science
scheduled for April 18 and 19, 2006.
This meeting was announced in the
Federal Register of February 16, 2006
(71 FR 8307).
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
Mimi T. Phan, Center for Drug
Evaluation and Research (HFD–21),
Food and Drug Administration, 5600
Fishers Lane (for express delivery, rm.
1093), Rockville, MD 20857, 301–827–
7001, FAX: 301–827–6776, e-mail:
mimi.phan@fda.hhs.gov, or FDA
Advisory Committee Information Line,
1–800–741–8138(301–443–0572 in the
Washington, DC area) code 3014512539.
sroberts on PROD1PC70 with NOTICES
Dated: March 10, 2006.
Jason Brodsky,
Acting Associate Commissioner for External
Relations.
[FR Doc. E6–3851 Filed 3–16–06; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Dental &
Craniofacial Research; Notice of
Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. Appendix 2), notice
is hereby given of the following
meeting.
The meeting 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.
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. Appendix 2), notice
is hereby given of the following
meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in section 552b(c)(4)
and 552b(c)(6), Title 5 U.S.C., as
amended. The grant applications and
the discussions could disclosed
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 Heart, Lung,
and Blood Institute Special Emphasis Panel,
Training Programs (T32s and T35s).
Date: May 26, 2006.
Time: 8 a.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: Bethesda, Marriott, 5151 Pooks Hill
Road, Bethesda, MD 20814.
Contact Person: Charles Joyce, PhD,
Scientific Review Administrator, Review
Branch, NHLBI, National Institutes of Health,
6701 Rockledge Drive, Room 7196, Bethesda,
MD 20892. 301–435–0288.
cjoyce@nhlbi.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.233, National Center for
Sleep Disorders Research; 93.837, Heart and
Vascular Diseases Research; 93.838, Lung
Diseases Research; 93.839, Blood Diseases
and Resources Research, National Institutes
of Health, HHS).
Dated: March 9, 2006.
Anna Snouffer,
Acting Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 06–2575 Filed 3–16–06; 8:45 am]
BILLING CODE 4140–01–M
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16:52 Mar 16, 2006
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National Heart, Lung, and Blood
Institutes; Notice of Closed Meeting
BILLING CODE 4160–01–S
BILLING CODE 4160–01–S
VISTAKON (SENOFILCON A)
CONTACT LENS, CLEAR AND
VISIBILITY TINTED WITH UV
BLOCKER
National Institutes of Health
Dated: March 7, 2006.
Linda S. Kahan,
Deputy Director, Center for Devices and
Radiological Health.
[FR Doc. E6–3850 Filed 3–16–06; 8:45 am]
ACTION:
Approval Date
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Persons with access to the Internet
may obtain the documents at https://
www.fda.gov/cdrh/pmapage.html.
AGENCY:
Trade Name
PO 00000
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Name of Committee: National Institute of
Dental and Craniofacial Research Special
Emphasis Panel, 06–50, Review FRA DE–06–
005, Orofacial Pain.
Date: April 20, 2006.
Time: 8 a.m. to 6 p.m.
Agenda: To review and evaluate grant
applications.
Place: Bethesda Marriott, 5151 Pooks Hill
Road, Bethesda, MD 20814.
Contact Person: H. George Hausch, Ph.D.,
Acting Director, 45 Center Drive, Natcher
Building, Rm. 4AN44F, National Inst. of
Dental & Craniofacial Research, National
Institutes of Health, Bethesda, MD 20892.
(301) 594–2904, george_hausch@nih.gov.
Name of Committee: National Institute of
Dental and Craniofacial Research Special
Emphasis Panel, 06–69, Review R21s.
Date: April 24, 2006.
Time: 3:30 p.m. to 4:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Natcher Building, 45 Center Drive, Bethesda,
MD 20892, (Telephone Conference Call).
Contact Person: Lynn M. King, Ph.D.,
Scientific Review Administrator, Scientific
Review Branch, 45 Center Dr., Rm. 4AN–32F,
National Inst. of Dental & Craniofacial
Research, National Institutes of Health,
Bethesda, MD 20892–6402. (301) 594–5006,
lynn.king@nih.gov.
Name of Committee: National Institute of
Dental and Craniofacial Research Special
Emphasis Panel, 06–59, Review RFA DE–06–
007.
E:\FR\FM\17MRN1.SGM
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]]>Agencies
[Federal Register Volume 71, Number 52 (Friday, March 17, 2006)]
[Notices]
[Pages 13855-13856]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-3850]
[[Page 13855]]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. 2005M-0435, 2005M-0475, 2005M-0473, 2005M-0478, 2005M-
0454, 2005M-0399, 2005M-0477, 2005M-0476, 2005M-0492, 2005M-0474,
2005M-0504]
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 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: Thinh Nguyen, Center for Devices and
Radiological Health (HFZ-402), Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850, 301-594-2186 ext. 152.
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 October 1, 2005 through December 31,
2005. 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 October 1, 2005 through December 31, 2005
------------------------------------------------------------------------
PMA No./Docket
No. Applicant Trade Name Approval Date
------------------------------------------------------------------------
P960040(S28)/ Guidant CRM Corp. VENTAK PRIZM AVT March 27, 2003
2005M-0435 AICD SYSTEM
------------------------------------------------------------------------
P020045/2005M- CryoCath 7F FREEZOR April 17, 2003
0475 Technologies, CARDIAC
Inc. CRYOBLATION
CATHETER &
CCT.2
CRYOCONSOLE
SYSTEM
------------------------------------------------------------------------
P040003/2005M- InSightec--North EXABLATE 2000 October 22, 2004
0473 America SYSTEM
------------------------------------------------------------------------
P030056/2005M- Bayer Healthcare, ADVIA CENTAUR December 22,
0478 LLC HCV READY PACK 2004
REAGENTS, ADVIA
CENTAUR HCV
QUALITY CONTROL
MATERIALS
------------------------------------------------------------------------
P980022(S11)/ Medtronic MiniMed GUARDIAN RT July 18, 2005
2005M-0454 CONTINUOUS
GLUCOSE
MONITORING
SYSTEM
------------------------------------------------------------------------
P020016/2005M- Walter Lorenz TOTAL September 21,
0399 Surgical, Inc. TEMPOMANDIBULAR 2005
JOINT
REPLACEMENT
SYSTEM
------------------------------------------------------------------------
P040047/2005M- Bioform Medical, COAPTITE November 10,
0477 Inc. 2005
------------------------------------------------------------------------
P040042/2005M- Irvine THERAPY DUAL 8 November 18,
0476 Biomedical, Inc. CARDIAC 2005
ABLATION SYSTEM
------------------------------------------------------------------------
P030054(S10)/ St. Jude Medical EPIC & ATLAS + November 18,
2005M-0492 CRMD HF CRT-D 2005
SYSTEMS
------------------------------------------------------------------------
P040013/2005M- Biomimetic GEM 21S (GROWTH- November 18,
0474 Therapeutics, FACTOR ENHANCED 2005
Inc. MATRIX)
------------------------------------------------------------------------
[[Page 13856]]
P040045/2005M- Vistakon, VISTAKON December 20,
0504 Division of (SENOFILCON A) 2005
Johnson & CONTACT LENS,
Johnson Vision CLEAR AND
Care, Inc. VISIBILITY
TINTED WITH UV
BLOCKER
------------------------------------------------------------------------
II. Electronic Access
Persons with access to the Internet may obtain the documents at
https://www.fda.gov/cdrh/pmapage.html.
Dated: March 7, 2006.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. E6-3850 Filed 3-16-06; 8:45 am]
BILLING CODE 4160-01-S
