[Federal Register: January 9, 2006 (Volume 71, Number 5)]
[Notices]
[Page 1430-1432]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr09ja06-35]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. 2005M-0320, 2005M-0289, 2005M-0387, 2005M-0270, 2005M-
0379, 2005M-0388, 2005M-0284, 2005M-0283, 2005M-0328, 2005M-0308,
2005M-0380, 2005M-0321, 2005M-0339, 2005M-0359, 2005M-0382, 2005M-0381,
2005M-0378]
Medical Devices; Availability of Safety and Effectiveness
Summaries for Premarket Approval Applications
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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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: Nicole Wolanski, Center for Devices
and Radiological Health (HFZ-402), Food and Drug Administration, 9200
[[Page 1431]]
Corporate Blvd., Rockville, MD 20850, 301-594-2186.
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 http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://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 July 1, 2005, through September 30,
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 July 1, 2005, through September 30, 2005
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Approval
PMA No./Docket No. Applicant Trade name date
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P040043/2005M-0320 W.L. Gore & GORE TAG THORACIC March 23,
Associates, ENDOPROSTHESIS 2005
Inc.
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P030035(S3)/2005M- St. Jude Medical FRONTIER MODEL April 29,
0289 5508L AND 2005
FRONTIER II
MODEL 5586
CARDIAC
RESYNCHRONIZATIO
N THERAPY
PACEMAKERS (CRT-
P) SUPPORTED ON
THE MODEL 3510
PROGRAMMER
PLATFORMS WITH
THE MODEL 3307,
V4.8M PROGRAMMER
SOFTWARE
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P040005/2005M-0387 DakoCytomation DAKOCYTOMATION May 3, 2005
Denmark A/S HER2 FISH
PHARMDX KIT
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P030049/2005M-0270 Bayer ADVIA CENTAUR May 26, 2005
Healthcare, LLC HBSAG READY PACK
REAGENTS/
CONFIRMATORY
READY PACK
REAGENTS/QUALITY
CONTROL MATERIAL
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P040037/2005M-0379 W.L. Gore & VIABAHN June 14,
Associates, ENDOPROSTHESIS 2005
Inc.
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P040011/2005M-0388 DakoCytomation DAKOCYTOMATION C- June 27,
California, KIT PHARMDX 2005
Inc.
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P950042(S3)/2005M- Xillix ONCO-LIFE June 30,
0284 Technologies ENDOSCOPIC LIGHT 2005
Corp. SOURCE AND VIDEO
CAMERA
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P970003(S50)/2005M- Cyberonics, Inc. VNS THERAPY July 15,
0283 SYSTEM 2005
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P030004/2005M-0328 Micro ONYX LIQUID July 21,
Therapeutics, EMBOLIC SYSTEM 2005
Inc.
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H050001/2005M-0308 Boston WINGSPAN STENT August 3,
Scientific SYSTEM WITH 2005
Smart GATEWAY PTA
BALLOON CATHETER
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P030036/2005M-0380 Medtronic, Inc. MEDTRONIC August 3,
SELECTSECURE 2005
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P040021/2005M-0321 St. Jude SJM BIOCOR VALVE/ August 5,
Medical, Inc. SJM BICOR SUPRA 2005
VALVE
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P040039/2005M-0339 Orthometrix, ORBASONE PAIN August 10,
Inc. RELIEF SYSTEM 2005
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[[Page 1432]]
P040044/2005M-0359 Access Closure, MATRIX VSG SYSTEM August 17,
Inc. MODEL MX-100 2005
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P930016(S21)/2005M- Visx, Inc. STAR S4 IR August 30,
0382 EXCIMER LASER 2005
SYSTEM WITH
VARIABLE SPOT
SCANNING (VSS)
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P040038/2005M-0381 Abbott Vascular XACT CAROTID September 6,
Devices STENT SYSTEM 2005
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P930014(S15)/2005M- Alcon ACRYSOF TORIC September
0378 Laboratories POSTERIOR 14, 2005
CHAMBER
INTRAOCULAR LENS
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II. Electronic Access
Persons with access to the Internet may obtain the documents at
http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cdrh/pmapage.html.
Dated: December 20, 2005.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. E6-59 Filed 1-6-06; 8:45 am]
BILLING CODE 4160-01-S