[Federal Register Volume 72, Number 63 (Tuesday, April 3, 2007)]
[Notices]
[Pages 15885-15886]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-6166]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. 2006M-0411, 2006M-0512, 2006M-0412, 2006M-0396, 2006M-
0460, 2006M-0456, 2006M-0459, 2006M-0455, 2006M-0457, 2006M-0473, 
2006M-0490, 2006M-0492, 2006M-0529, 2006M-0530 and 2006M-0531]


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

[[Page 15886]]

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 Web site 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, 2006, through December 31, 
2006. 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, 2006, through December 31, 2006.
------------------------------------------------------------------------
 PMA No./Docket                                                Approval
      No.           Applicant            Trade Name              Date
------------------------------------------------------------------------
P040027/2006M-   W.L. Gore &     GORE VIATORR TIPS           December 6,
 0411             Associates                                  2004
------------------------------------------------------------------------
P040023/2006M-   DePuy           DURALOC OPTION CERAMIC HIP  May 3, 2005
 0512             Orthopedics,    SYSTEM
                  Inc.
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P030047/2006M-   Cordis Corp.    CORDIS PRECISE NITINOL      September
 0412                             STENT                       22, 2006
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P050038/2006M-   Medafor, Inc.   ARISTA AH ABSORBABLE        September
 0396                             HEMOSTATIC, NON-COLLAGEN    26, 2006
                                  BASED
------------------------------------------------------------------------
P970053(S9)/     Nidek, Inc.     NIDEK EC-5000 EXCIMER       October 11,
 2006M-0460                       LASER                       2006
------------------------------------------------------------------------
P050022/2006M-   Siemens         SYNGO LUNG COMPUTER         October 18,
 0456             Medical         ASSISTED DETECTION (CAD)    2006
                  Solutions       SYSTEM
                  USA, Inc.
------------------------------------------------------------------------
P050025/2006M-   Endotex          ENDOTEX NEXSTENT CAROTID   October 27,
 0459             Interventiona   STENT & DELIVERY SYSTERM;   2006
                  l Systems,      AND ENDOTEX NEXSTENT
                  Inc.            CAROTID STENT & MONORAIL
                                  DELIVERY SYSTERM
------------------------------------------------------------------------
P020012/2006M-   Artes Medical   ARTEFILL                    October 27,
 0455             USA, Inc.                                   2006
------------------------------------------------------------------------
P040050/2006M-   Uroplasty,      MACROPLASTIQUE IMPLANTS     October 30,
 0457             Inc.                                        2006
------------------------------------------------------------------------
P050031/2006M-   Paragon Vision  PARAGON Z CRT               November
 0473             Sciences                                    16, 2006
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P020056/2006M-   Allergan        INAMED SILICONE-FILLED      November
 0490                             BREAST IMPLANTS             17, 2006
------------------------------------------------------------------------
P030053/2006M-   Mentor Corp.    MENTOR MEMORYGEL SILICONE   November
 0492                             GEL-FILLED BREAST           17, 2006
                                  IMPLANTS
------------------------------------------------------------------------
P060010/2006M-   AbbeyMoor       THE SPANNER TEMPORARY       December
 0529             Medical, Inc.   PROSTATIC STENT             14, 2006
------------------------------------------------------------------------
P040025/2006M-   Olympic         OLYMPIC COOL-CAP            December
 0530             Medical                                     20, 2006
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P050033/2006M-   Anika           COSMETIC TISSUE             December
 0531             Therapeutics,   AUGMENTATION PRODUCT        20, 2006
                  Inc.
------------------------------------------------------------------------

II. Electronic Access

    Persons with access to the Internet may obtain the documents at 
http://www.fda.gov/cdrh/pmapage.html.

    Dated: March 22, 2007.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. E7-6166 Filed 4-2-07; 8:45 am]
BILLING CODE 4160-01-S