[Federal Register Volume 71, Number 5 (Monday, January 9, 2006)]
[Notices]
[Pages 1430-1432]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-59]


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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://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
------------------------------------------------------------------------
                                                              Approval
  PMA No./Docket No.       Applicant         Trade name         date
------------------------------------------------------------------------
P040043/2005M-0320     W.L. Gore &       GORE TAG THORACIC  March 23,
                        Associates,       ENDOPROSTHESIS     2005
                        Inc.
------------------------------------------------------------------------
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
------------------------------------------------------------------------
P040005/2005M-0387     DakoCytomation    DAKOCYTOMATION     May 3, 2005
                        Denmark A/S       HER2 FISH
                                          PHARMDX KIT
------------------------------------------------------------------------
P030049/2005M-0270     Bayer             ADVIA CENTAUR      May 26, 2005
                        Healthcare, LLC   HBSAG READY PACK
                                          REAGENTS/
                                          CONFIRMATORY
                                          READY PACK
                                          REAGENTS/QUALITY
                                          CONTROL MATERIAL
------------------------------------------------------------------------
P040037/2005M-0379     W.L. Gore &       VIABAHN            June 14,
                        Associates,       ENDOPROSTHESIS     2005
                        Inc.
------------------------------------------------------------------------
P040011/2005M-0388     DakoCytomation    DAKOCYTOMATION C-  June 27,
                        California,       KIT PHARMDX        2005
                        Inc.
------------------------------------------------------------------------
P950042(S3)/2005M-     Xillix            ONCO-LIFE          June 30,
 0284                   Technologies      ENDOSCOPIC LIGHT   2005
                        Corp.             SOURCE AND VIDEO
                                          CAMERA
------------------------------------------------------------------------
P970003(S50)/2005M-    Cyberonics, Inc.  VNS THERAPY        July 15,
 0283                                     SYSTEM             2005
------------------------------------------------------------------------
P030004/2005M-0328     Micro             ONYX LIQUID        July 21,
                        Therapeutics,     EMBOLIC SYSTEM     2005
                        Inc.
------------------------------------------------------------------------
H050001/2005M-0308     Boston            WINGSPAN STENT     August 3,
                        Scientific        SYSTEM WITH        2005
                        Smart             GATEWAY PTA
                                          BALLOON CATHETER
------------------------------------------------------------------------
P030036/2005M-0380     Medtronic, Inc.   MEDTRONIC          August 3,
                                          SELECTSECURE       2005
------------------------------------------------------------------------
P040021/2005M-0321     St. Jude          SJM BIOCOR VALVE/  August 5,
                        Medical, Inc.     SJM BICOR SUPRA    2005
                                          VALVE
------------------------------------------------------------------------
P040039/2005M-0339     Orthometrix,      ORBASONE PAIN      August 10,
                        Inc.              RELIEF SYSTEM      2005
------------------------------------------------------------------------

[[Page 1432]]

 
P040044/2005M-0359     Access Closure,   MATRIX VSG SYSTEM  August 17,
                        Inc.              MODEL MX-100       2005
------------------------------------------------------------------------
P930016(S21)/2005M-    Visx, Inc.        STAR S4 IR         August 30,
 0382                                     EXCIMER LASER      2005
                                          SYSTEM WITH
                                          VARIABLE SPOT
                                          SCANNING (VSS)
------------------------------------------------------------------------
P040038/2005M-0381     Abbott Vascular   XACT CAROTID       September 6,
                        Devices           STENT SYSTEM       2005
------------------------------------------------------------------------
P930014(S15)/2005M-    Alcon             ACRYSOF TORIC      September
 0378                   Laboratories      POSTERIOR          14, 2005
                                          CHAMBER
                                          INTRAOCULAR LENS
------------------------------------------------------------------------

II. Electronic Access

    Persons with access to the Internet may obtain the documents at 
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