[Federal Register: September 30, 2004 (Volume 69, Number 189)]
[Page 58446-58448]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

[Docket Nos. 2004M-0147, 2004M-0145, 2004M-0207, 2004M-0253, 2004M-
0165, 2004M-0200, 2004M-0199, 2004M-0256, 2004M-0248, 2004M-0249, 
2004M-0250, 2004M-0260, and 2004M-0259]

Medical Devices; Availability of Safety and Effectiveness 
Summaries for Premarket Approval Applications

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.


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

[[Page 58447]]

Radiological Health (HFZ-402), Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850, 301-594-2186.


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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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 
    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, 2004, through June 30, 2004. 
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, 2004 through June 30, 2004.
 PMA No./Docket
       No.            Applicant          Trade Name       Approval Date
P890064(S9)/      Digene            DIGENE HYBRID        March 31, 2003
 2004M-0147        Diagnostics,      CAPTURE 2 (HC2)
                   Inc.              HIGH-RISK HPV DNA
P020006/2004M-    Enteric Medical   ENTERYX PROCEDURE    April 22, 2003
 0145              Technologies,     KIT
P970027/2004M-    Abbott            ABBOTT AXSYM         February 5,
 0207              Laboratories      ANTIBODY TO HCV      2004
P980007/2004M-    Abbott            AXSYM FREE PSA       February 5,
 0253              Laboratories                           2004
H020008/2004M-    Stryker Biotech   OP-1 PUTTY           April 7, 2004
P010014/2004M-    Biomet, Inc.      OXFORD MENISCAL      April 21, 2004
 0200                                UNICOMPARTMENTAL
                                     KNEE SYSTEM
P030032/2004M-    Genzyme           HYLAFORM (HYLAN B    April 22, 2004
 0199              Biosurgery        GEL)
P030017/2004M-    Advanced Bionics  Precision Spinal     April 27, 2004
 0256              Corp.             Cord Stimulation
                                     (SCS) System
P030023/2004M-    Ophtec USA, Inc.  OCULAID/STABLEYES    April 27, 2004
 0248                                CAPULAR TENSION
P000054/2004M-    Wyeth             INFUSE BONE GRAFT    April 30, 2004
 0249              Pharmaceuticals
                   , Inc.
P030035/2004M-    St. Jude Medical  ST. JUDE FRONTIER    May 13, 2004
 0250                                BIVENTRICULAR
                                     CARDIAC PACING
P010062/2004M-    Euclid Systems    EUCLID SYSTEMS       June 7, 2004
 0260              Corp.             ORTHOKERATOLOGY
                                     (OPRIFOCOM A)
                                     CONTACT LENS FOR
                                     OVERNIGHT WEAR
P030045/2004M-    Ev3 Inc.          INTRASTENT           June 8, 2004
 0259                                DOUBLESTRUT STENT

[[Page 58448]]

II. Electronic Access

    Persons with access to the Internet may obtain the documents at 

    Dated: September 23, 2004.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. 04-21873 Filed 9-29-04; 8:45 am]