[Federal Register Volume 72, Number 17 (Friday, January 26, 2007)]
[Notices]
[Pages 3863-3865]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-1199]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. 2006M-0339, 2006M-0338, 2006M-0340, 2006M-0323, 2006M-
0324, 2006M-0321, 2006M-0389, 2006M-0293, 2006M-0294, 2006M-0295, 
2006M-0325, 2006M-0322, 2006M-0367, 2006M-0374, 2006M-0342, 2006M-0341, 
2006M-0343, 2006M-0368]


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, 240-276-4010, 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

[[Page 3864]]

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 July 1, 2006, through September 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 July 1, 2006, through September 30, 2006
------------------------------------------------------------------------
 PMA No./Docket                                               Approval
      No.           Applicant            Trade Name             Date
------------------------------------------------------------------------
P030019/2006M-   Anika           ORTHOVISC HIGH MOLECULAR   February 4,
 0339             Therapeutics,   WEIGHT HYALURONAN          2004
                  Inc.
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P010029/2006M-   Ferring         NUFLEXXA (1% SODIUM        December 3,
 0338             Pharmaceutica   HYALURONATE)               2004
                  ls, Inc./
                  applicant at
                  approval was
                  Savient
                  Pharmaceutica
                  ls, Inc.
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P030016/2006M-   Staar Surgical  VISIAN ICL (IMPLANTABLE    December 22,
 0340             Co.             COLLAMER LENS)             2005
------------------------------------------------------------------------
P970043(S20)/    Alcon           LADARVISION 4000 EXCIMER   May 1, 2006
 2006M-0323       Laboratories,   LASER SYSTEM
                  Inc.
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P970043(S22)/    Alcon           LADARVISION 4000 EXCIMER   May 2, 2006
 2006M-0324       Laboratories,   LASER SYSTEM
                  Inc.
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P050051/2006M-   Abbott          ABBOTT ARCHITECT AUSA-B    June 1, 2006
 0321             Laboratories,
                  Inc.
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P050042/2006M-   Abbott          ARCHITECT ANTI-HCV ASSAY;  June 7, 2006
 0389             Laboratories,   ARCHITECT ANTI-HCV
                  Inc.            CALIBRATOR; AND
                                  ARCHITECT ANTI-HCV
                                  CONTROL
------------------------------------------------------------------------
P050044/2006M-   Orthovita,      VITAGEL SURGICAL HEMOSTAT  June 16,
 0293             Inc.                                       2006
------------------------------------------------------------------------
P050017/2006M-   Cook            ZILVER VASCULAR STENT      June 26,
 0294             Incorporated                               2006
------------------------------------------------------------------------
P050014/2006M-   Fujifilm        FUJI'S COMPUTED            July 10,
 0295             Medical         RADIOGRAPHY MAMMOGRAPHY    2006
                  System USA,     SUITE (FCRMS)
                  Inc.
------------------------------------------------------------------------
P020050(S4)/     Wavelight AG/   WAVELIGHT ALLEGRETTO WAVE  July 26,
 2006M-0325       applicant at    EXCIMER LASER SYSTEM       2006
                  approval was
                  SurgiVision
                  Regulatory
                  Consultants,
                  Inc.
------------------------------------------------------------------------
P050011/2006M-   Baxter          ADEPT (4% ICODEXTRIN)      July 28,
 0322             Healthcare      ADHESION REDUCTION         2006
                  Corp./          SOLUTION
                  applicant at
                  approval was
                  Innovata PLC
------------------------------------------------------------------------
P050023/2006M-   Biotronik,      TUPOS LV/ATX & KRONOS LV-  August 10,
 0367             Inc.            T CRT-D & COROX OWT        2006
                                  STEROID PACING LEAD
------------------------------------------------------------------------
P040036/2006M-   Biosense        NAVISTAR THERMOCOOL        August 11,
 0374             Webster, Inc.   DEFLECTABLE DIAGNOSTIC     2006
                                  ABLATION CATHETER
------------------------------------------------------------------------
P060004/2006M-   Carl Zeiss,     MEL 80 EXCIMER LASER       August 11,
 0342             Inc./                                      2006
                  applicant at
                  approval was
                  Carl Zeiss
                  Meditec, Inc.
------------------------------------------------------------------------
P050006/2006M-   WL Gore &       GORE HELEX SEPTAL          August 11,
 0341             Associates,     OCCLUDER                   2006
                  Inc.
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P050010/2006M-   Synthes Spine/  PRODISC-L TOTAL DISC       August 14,
 0343             applicant at    REPLACEMENT                2006
                  approval was
                  Synthes Spine
                  Co., L.P.
------------------------------------------------------------------------
H040006/2006M-   Abiomed, Inc.   ABICOR IMPLANTABLE         September 5,
 0368                             REPLACEMENT HEART          2006
------------------------------------------------------------------------


[[Page 3865]]

II. Electronic Access

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

    Dated: January 16, 2007.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. E7-1199 Filed 1-25-07; 8:45 am]
BILLING CODE 4160-01-S