[Federal Register Volume 71, Number 52 (Friday, March 17, 2006)]
[Notices]
[Pages 13855-13856]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-3850]



[[Page 13855]]

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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.

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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: 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 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 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 
http://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