[Federal Register Volume 71, Number 186 (Tuesday, September 26, 2006)]
[Notices]
[Pages 56157-56158]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-15755]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. 2006M-0161, 2006M-0264, 2006M-0148, 2006M-0200, 2006M-
0162, 2006M-0199, 2006M-0193, 2006M-0235]


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

[[Page 56158]]

(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 April 1, 2006, through June 30, 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 April 1, 2006, through June 30, 2006
------------------------------------------------------------------------
 PMA No./Docket                                                Approval
      No.           Applicant            Trade Name              Date
------------------------------------------------------------------------
P050021/2006M-   QLT, Inc.       CERALAS I LASER & CERALINK  December
 0161                             SLIT LAMP ADAPTER           20, 2005
------------------------------------------------------------------------
P040052/2006M-   MonoGen, Inc.   MONOPREP PAP TEST (MPPT)    March 3,
 0264                                                         2006
------------------------------------------------------------------------
P040028/2006M-   Medispectra,    LUMA CERVICAL IMAGING       March 16,
 0148             Inc.            SYSTEM                      2006
------------------------------------------------------------------------
P050012/2006M-   Dexcom, Inc.    DEXCOM (STS) CONTINUOUS     March 24,
 0200                             GLUCOSE MONITORING SYSTEM   2006
------------------------------------------------------------------------
P050026/2006M-   QLT, Inc.       QUALTEL ACTIVIS LASER &     April 4,
 0162                             ZSL30 ACT, ZSL120 ACT,      2006
                                  and HSBMBQ ACT SLIT LAMP
                                  ADAPTERS
------------------------------------------------------------------------
P030008(S4)/     SurgiVision     WAVELIGHT ALLEGRETTO WAVE   April 19,
 2006M-0199       Refractive      EXCIMER LASER SYSTEM        2006
                  Consultants
------------------------------------------------------------------------
P040033/2006M-   Smith & Nephew  BIRMINGHAM HIP RESURFACING  May 9, 2006
 0193             Orthopaedics    (BHR) SYSTEM
------------------------------------------------------------------------
P050047/2006M-   Inamed Corp.    JUVEDERM 24HV, JUVEDERM     June 2,
 0235                             30, and JUVEDERM 30HV GEL   2006
                                  IMPLANTS
------------------------------------------------------------------------

II. Electronic Access

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

    Dated: September 15, 2006.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. E6-15755 Filed 9-25-06; 8:45 am]
BILLING CODE 4160-01-S