[Federal Register Volume 67, Number 99 (Wednesday, May 22, 2002)]
[Notices]
[Pages 36009-36011]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-12728]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. 01M-0478, 01M-0460, 01M-0454, 01M-0453, 01M-0452, 01M-
0456, 01M-0451, 01M-0455, 01M-0578, 01M-0507, 01M-0579, 01M-0535, 01M-
0462, 01M-0461, 01M-0536, 01M-0520, 01M-0439, 01M-0509, 01M-0490, 01M-
0498, 01M-0479, 01M-0480, 01M-0482, 01M-0508, 01M-0522, 01M-0537, 01M-
0523, 01M-0530, 01M-0531, 01M-0534, 01M-0567, 01M-0581]


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 Dockets Management Branch.

ADDRESSES:  Submit written requests for copies of summaries of safety 
and effectiveness to the Dockets Management Branch (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.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of January 30, 1998 (63 FR 4571), FDA 
published a final rule to revise  814.44(d) and 
814.45(d) (21 CFR 814.44(d) and 814.45(d)) to discontinue publication 
of individual PMA approvals and denials in the Federal Register. 
Instead, revised  814.44(d) and 814.45(d) state that 
FDA will notify the public of PMA approvals and denials by posting them 
on FDA's home page at http://www.fda.gov on the Internet, by placing 
the summaries of safety and effectiveness on the Internet and in FDA's 
Dockets Management Branch, and by publishing in the Federal Register 
after each quarter a list of available safety and effectiveness 
summaries of approved PMAs and denials announced in that quarter.
    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.

[[Page 36010]]

 The 30-day period for requesting reconsideration of an FDA action 
under  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 following is a list of approved PMAs for which summaries of 
safety and effectiveness were placed on the Internet in accordance with 
the procedure explained previously from October 1, 2001, through 
December 31, 2001. 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 October 1, 2001, through December 31, 2001
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PMA No./Docket                                                 Approval
      No.            Applicant             Trade Name            Date
------------------------------------------------------------------------
P990050/01M-    Spectrascience,     Optical Biopsy System    November
 0478            Inc.                                         14, 2000
P000020/01M-    C.R. Bard, Inc.     Stinger Ablation         November
 0460                                Catheter Templink        29, 2000
                                     Extension Cable
P990043/01M-    Diasorin, Inc.      DIASORIN ETI-EBK PLUS    February 8,
 0454                                Assay                    2001
P990042/01M-    Diasorin, Inc.      DIASORIN ETI-AB-AUK      March 30,
 0453                                PLUS Assay               2001
P990041/01M-    Diasorin, Inc.      DIASORIN ETI-AB-EBK      March 30,
 0452                                PLUS Assay               2001
P990045/01M-    Diasorin, Inc.      DIASORIN ETI-AB-COREK    March 30,
 0456                                PLUS Assay               2001
P990038/01M-    Diasorin, Inc.      DIASORIN ETI MAK-2 PLUS  March 30,
 0451                                Assay                    2001
P990044/01M-    Diasorin, Inc.      DIASORIN ETI-CORE IGMK   March 30,
 0455                                PLUS Assay               2001
P000040/01M-    Bei Medical         HYDROTHERMABLATOR        April 20,
 0578            Systems Co., Inc.   Endometrial Ablation     2001
                                     System
P990012/01M-    Roche Diagnostics   Elecsys Hbsag            June 1,
 0507            Corp.               Immunoassay, Elecsys     2001
                                     Hbsag Confirmatory,
                                     and Precicontrol Hbsag
P000053/01M-    American Medical    AMS SPHINCTER 800        June 14,
 0579            Systems, Inc.       Urinary Control System   2001
P930027(S004)/  Diagnostic          Immulite PSA, Immulite   June 19,
 01M-0535        Products Corp.      Third Generation PSA,    2001
                                     Immulite 2000
P880086(S083)/  St. Jude Medical,   Integrity AFX DR Model   July 11,
 01M-0462        Inc.                5346 Dual Chamber        2001
                                     Pulse Generator and
                                     Programmer Software
                                     Model 3307, V2.2a
P830045(S076)/  St. Jude Medical,   Integrity AFX DR Model   July 11,
 01M-0461        Inc.                5346 Dual Chamber        2001
                                     Pulse
P010021/01M-    Ortho-Clinical      Vitros Immunodiagnostic  August 30,
 0536            Diagnostics, Inc.   Products Anti-HCV        2001
                                     Reagent Pack and
                                     Calibrator
P890057(S014)/  Sensor Medics       Model 3100b High         September
 01M-0520        Corp.               Frequency Oscillatory    24, 2001
                                     Ventilator (HFOV)
P000029/01M-    Q-Med Ab            Deflux Injectable Gel    September
 0439                                Ren                      24, 2001
P010017/01M-    Fisher Imaging      SENOSCAN Full Field      September
 0509            Corp.               Digital Mammagraphy      25, 2001
                                     System
P980008(S005)/  Lasersight          Lasersight Laserscan     September
 01M-0490        Technologies,       Lsx Excimer Laser        28, 2001
                 Inc.                System For Laser-
                                     Assisted In Situ
                                     Keratomileusis (LASIK)
P000036/01M-    Advanced Tissue     Dermagraft               September
 0498            Sciences                                     28, 2001
P010019/01M-    Ciba Vision Corp.   Focus Night And Day      October 11,
 0479                                (Lotrafilcon A) Soft     2001
                                     Contact Lenses
P000030/01M-    Ciba Vision Corp.   Focus Night & Day        October 12,
 0480                                (Lotrafilcon A) Soft     2001
                                     Contact Lenses
H010002/01M-    Stryker Biotech     OP-1 Implant             October 17,
 0482                                                         2001
P000052/01M-    Guidant Corp.       Galileo Intravascular    November 2,
 0508                                Radiotherapy System      2001
P930016(S014)/  VISX, Inc.          VISX STAR Excimer Laser  November 6,
 01M-0522                            System                   2001
P010007/01M-    Diagnostic          Immulite/Immulite 2000   November 9,
 0537            Products Corp.      Afp Assays               2001
P990015/01M-    Lifecore            Intergel Adhesion        November
 0523            Biomedical, Inc.    Prevention Solution      16, 2001
P000057/01M-    Ascension           Ascension Mcp            November
 0530            Orthopedics, Inc.                            19, 2001
P980006(S004)/  Bausch & Lomb,      Purevision (Balafilcon   November
 01M-0531        Inc.                A) Visibility Tinted     20, 2001
                                     Contact Lenses
P010032/01M-    Advanced            Genesis                  November
 0534            Neuromodulation     Neurostimulation (Ipg)   21, 2001
                 System, Inc.        System
P010003/01M-    Cryolife, Inc.      BIOGLUE Surgical         December 3,
 0567                                Adhesive                 2001
P010020/01M-    American Medical    AMS Acticon              December
 0581            Systems, Inc.       Neosphincter             18, 2001
------------------------------------------------------------------------


[[Page 36011]]

II. Electronic Access

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

    Dated: May 10, 2002.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. 02-12728 Filed 5-21-02; 8:45 am]
BILLING CODE 4160-01-S