[Federal Register Volume 72, Number 177 (Thursday, September 13, 2007)]
[Notices]
[Pages 52380-52382]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-18034]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. 2007M-0174, 2007M-0259, 2007M-0161, 2007M-0160, 2007M-
0151, 2007M-0152, 2007M-0153, 2007M-0188, 2007M-0156, 2007M-0154, 
2007M-0180, 2007M-0189, 2007M-0190, 2007M-0253, 2007M-0255, 2007M-0254]


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 data 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: Samie Allen, Center for Devices and 
Radiological Health (HFZ-402), Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850, 240-276-4013.

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

[[Page 52381]]

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, 2007, through June 30, 2007. 
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, 2007, through June 30, 2007.
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   PMA No./                                                    Approval
  Docket No.       Applicant              TRADE NAME             Date
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P050049/2007M- Abbott             ABBOTT AXSYM HBSAG ASSAY    June 1,
 0174           Laboratories                                   2006
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P040048/2007M- Zimmer, Inc.       TRILOGY AB ACETBULAR        June 28,
 0259                              SYSTEM                      2006
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P060003/2007M- Abbott             AXSYM AUSAB REAGENT PACK,   August 7,
 0161           Laboratories       STANDARD CALIBRATORS,       2006
                                   CONTROLS
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P060009/2007M- Abbott             AXSYM CORE-M 2.0 & 2.0      August 25,
 0160           Laboratories       CONTROLS                    2006
------------------------------------------------------------------------
P050048/2007M- Bio-Rad            MONOLISA ANTI-HBS EIA       August 25,
 0151           Laboratories,                                  2006
                Inc.
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P060007/2007M- Abbott             ARCHITECT HBSAG REAGENT     September
 0152           Laboratories       KIT, CALIBRATORS,           7, 2006
                                   CONTROLS, CONFIRMATORY
                                   REAGENT KIT, CONFIRMATORY
                                   MANUAL DILUENT
------------------------------------------------------------------------
P060012/2007M- Abbott             AXSYM CORE 2.0 & AXSYM      September
 0153           Laboratories       CORE 2.0 CONTROLS           8, 2006
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P990037(S24)/  Vascular           VASCULAR SOLUTIONS D-STAT   December
 2007M-0188     Solutions, Inc.    FLOWABLE HEMOSTAT           22, 2006
------------------------------------------------------------------------
H060003/2007M- EV3 Neurovascular  ONYX LIQUID EMBOLIC SYSTEM  April 11,
 0156                              (ONYX HD-500, MODEL 105-    2007
                                   8101-500)
------------------------------------------------------------------------
P050046/2007M- Guidant Corp.      ACUITY STEERABLE LEAD       April 13,
 0154                              MODELS 4554, 4555, & 4556   2007
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P040024(S006)/ Medicis            PERLANE INJECTABLE GEL      May 2,
 2007M-0180     Aesthetics                                     2007
                Holdings, Inc.
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P060011/2007M- Rayner Surgical,   C-FLEX MODEL 570C           May 3,
 0189           Inc.               INTRAOCULAR LENS (IOL)      2007
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H060001/2007M- Cordis             ENTERPRISE VASCULAR         May 8,
 0190           Neurovascular,     RECONSTRUCTION DEVICE AND   2007
                Inc.               DELIVERY SYSTEM
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P050004/2007M- Electro Medical    EMS SWISS DOLORCLAST        May 8,
 0253           Systems (EMS)                                  2007
                S.A.
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P050012(S001)/ Dexcom, Inc.       STS-7 CONTINUOUS GLUCOSE    May 31,
 2007M-0255                        MONITORING SYSTEM           2007
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P060034/2007M- Bio-Rad            BIO RAD MONOLISA ANTI-HBC   May 31,
 0254           Laboratories       IGM EIA                     2007
------------------------------------------------------------------------


[[Page 52382]]

II. Electronic Access

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

    Dated: August 30, 2007.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. E7-18034 Filed 9-12-07; 8:45 am]
BILLING CODE 4160-01-S