[Federal Register: September 6, 2005 (Volume 70, Number 171)]
[Notices]               
[Page 53019-53021]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr06se05-64]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. 2005M-0158, 2005M-0159, 2005M-0129, 2005M-0160, 2005M-
0130, 2005M-0151, 2005M-0117, 2005M-0118, 2005M-0241, 2005M-0191, 
2005M-0192, 2005M-0193, 2005M-0270]

 
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

[[Page 53020]]

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.

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 April 1, 2005, through June 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 April 1, 2005,
                                             through June 30, 2005.
----------------------------------------------------------------------------------------------------------------
   PMA No./Docket No.          Applicant                        TRADE NAME                      Approval Date
----------------------------------------------------------------------------------------------------------------
P030040/2005M-0158       Bayer Healthcare, LLC  ADVIA CENTAUR HBC IGM READY PACK REAGENTS,  August 6, 2004
                                                ADVIA CENTAUR HBC IGM QUALITY CONTROL
                                                 MATERIAL
----------------------------------------------------------------------------------------------------------------
P020055/2005M-0159       Ventana Medical        VENTANA MEDICAL SYSTEMS PATHWAY ANTI-C-KIT  August 11, 2004
                          Systems, Inc.          (9.7)
                                                PRIMARY ANTIBODY
----------------------------------------------------------------------------------------------------------------
P040018/2005M-0129       Bayer Healthcare, LLC  ADVIA CENTAUR HAV IGM READY PACK REAGENTS,  December 22, 2004
                                                ADVIA CENTAUR HAV IGM QUALITY CONTROL
                                                 MATERIAL
----------------------------------------------------------------------------------------------------------------
P040030/2005M-0160       BioGenex               INSITE HER-2/NEU KIT                        December 22, 2004
                          Laboratories, Inc.
----------------------------------------------------------------------------------------------------------------
P030052/2005M-0130       Vysis, Inc.            UROVYSION BLADDER CANCER KIT                January 24, 2005
----------------------------------------------------------------------------------------------------------------
P930016(S20)/2005M-0151  VISX, Inc.             STAR S4 IR EXCIMER LASER SYSTEM WITH        March 17, 2005
                                                 VARIABLE
                                                SPOT SCANNING (VSS)
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P040020/2005M-0117       Alcon Research, Ltd.   ACRYSOF RESTOR APODIZED DIFFRACTIVE OPTIC   March 21, 2005
                                                POSTERIOR CHAMBER IOL
----------------------------------------------------------------------------------------------------------------
P040024/2005M-0118       Medicis Aesthetics     RESTYLANE INJECTABLE GEL                    March 25, 2005
                          Holdings, Inc.
----------------------------------------------------------------------------------------------------------------
P040026/2005M-0241       Medispec, Ltd.         ORTHOSPEC EXTRACORPOREAL SHOCK WAVE         April 1, 2005
                                                 THERAPY DEVICE
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P040034/2005M-0191       Confluent Surgical,    DURASEAL DURAL SEALANT SYSTEM               April 7, 2005
                          Inc.
----------------------------------------------------------------------------------------------------------------
P040016/2005M-0192       Boston Scientific      BOSTON SCIENTIFIC CORPORATION LIBERTE       April 12, 2005
                          Corp.                  MONORAIL
                                                AND OVER-THE-WIRE CORONARY STENT SYSTEMS
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P030037/2005M-0193       Biotronik, Inc.        RITHRON-XR CORONARY STENT SYSTEM            April 29, 2005
----------------------------------------------------------------------------------------------------------------
P030049/2005M-0270       Bayer Healthcare, LLC  ADVIA CENTAUR HBS AG READY PACK REAGENTS,   May 31, 2005
                                                 ADVIA CENTAUR HBS AG CONFIRMATORY READY
                                                 PACK REAGENTS, AND ADVIA CENTAUR HBS AG
                                                 QUALITY CONTROL MATERIAL
----------------------------------------------------------------------------------------------------------------


[[Page 53021]]

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: August 22, 2005.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. 05-17602 Filed 9-2-05; 8:45 am]

BILLING CODE 4160-01-S