[Federal Register Volume 67, Number 137 (Wednesday, July 17, 2002)]
[Notices]
[Pages 46990-46991]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-18038]



[[Page 46990]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. 02M-0083, 02M-0082, 02M-0006, 02M-0128, 02M-0076, 02M-
0034, 02M-0030, 02M-0060, 02M-0118, 02M-0121, and 02M-0134]


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 Secs. 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 
Secs. 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 on the 
Internet at http://www.fda.gov, 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. 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 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 January 1, 2002, through March 
31, 2002. 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 January 1, 2002, through March 31, 2002
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PMA Number/Docket
       No.             Applicant         Trade Name       Approval Date
------------------------------------------------------------------------
P000012/02M-0083   Roche Molecular    COBAS AMPLICOR    July 3, 2001.
                    Systems, Inc.      Hepatitis C
                                       Virus Test,
                                       version 2.0.
P000010/02M-0082   Roche Molecular    AMPLICOR          July 5, 2001.
                    Systems, Inc.      Hepatitis C
                                       Virus Test,
                                       version 2.0.
P000025/02M-0006   Med-El Corp.       MED-EL COMBI 40+  August 20, 2001.
                                       Cochlear
                                       Implant System.
P010013/02M-0128   Novacept, Inc.     NOVASURE          September 28,
                                       Impedance         2001.
                                       Controlled
                                       Endometrial
                                       Ablation
                                       System.
P010022/02M-0076   Cohesion           COSEAL Surgical   December 14,
                    Technologies,      Sealant.          2001.
                    Inc.
P000048/02M-0034   Dornier Medical    DORNIER EPOS      January 15,
                    Systems, Inc.      ULTRA.            2002.
P010038/02M-0030   Intelligent        MAMMOREADER       January 15,
                    Systems            (Computer-Aided   2002.
                    Software, Inc.     Detection
                                       System For
                                       Mammography).
P010034/02M-0060   CADx Medical       SECOND LOOK       January 31,
                    Systems, Inc.      (Computer-Aided   2002.
                                       Detection
                                       System For
                                       Mammography).
P010040/02M-0118   Safeguard Medical  The               March 15, 2002.
                    Devices, Inc.      DISINTEGRATOR
                                       Insulin Needle
                                       Destruction
                                       Device.
H010005/02M-0121   Ascension          ASCENSION PIP.    March 22, 2002.
                    Orthopedics,
                    Inc.
P010049/02M-0134   SUB-Q, Inc.        QuickSeal         March 25, 2002.
                                       Femoral
                                       Arterial
                                       Closure System.
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[[Page 46991]]

II. Electronic Access

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

    Dated: July 5, 2002.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. 02-18038 Filed 7-16-02; 8:45 am]
BILLING CODE 4160-01-S