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 Department of Health and Human Services 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]
 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 
                        ( print page 58447)
                        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 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 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 § 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, 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 DateP890064(S9)/2004M-0147
Digene Diagnostics, Inc.
DIGENE HYBRID CAPTURE 2 (HC2) HIGH-RISK HPV DNA TEST
March 31, 2003P020006/2004M-0145
Enteric Medical Technologies, Inc.
ENTERYX PROCEDURE KIT
April 22, 2003P970027/2004M-0207
Abbott Laboratories
ABBOTT AXSYM ANTIBODY TO HCV
February 5, 2004P980007/2004M-0253
Abbott Laboratories
AXSYM FREE PSA
February 5, 2004H020008/2004M-0165
Stryker Biotech
OP-1 PUTTY
April 7, 2004P010014/2004M-0200
Biomet, Inc.
OXFORD MENISCAL UNICOMPARTMENTAL KNEE SYSTEM
April 21, 2004P030032/2004M-0199
Genzyme Biosurgery
HYLAFORM (HYLAN B GEL)
April 22, 2004P030017/2004M-0256
Advanced Bionics Corp.
Precision Spinal Cord Stimulation (SCS) System
April 27, 2004P030023/2004M-0248
Ophtec USA, Inc.
OCULAID/STABLEYES CAPULAR TENSION RINGS
April 27, 2004P000054/2004M-0249
Wyeth Pharmaceuticals, Inc.
INFUSE BONE GRAFT
April 30, 2004P030035/2004M-0250
St. Jude Medical
ST. JUDE FRONTIER BIVENTRICULAR CARDIAC PACING SYSTEM
May 13, 2004P010062/2004M-0260
Euclid Systems Corp.
EUCLID SYSTEMS ORTHOKERATOLOGY (OPRIFOCOM A) CONTACT LENS FOR OVERNIGHT WEAR
June 7, 2004P030045/2004M-0259
Ev3 Inc.
INTRASTENT DOUBLESTRUT STENT
June 8, 2004
 
 
 II.  Electronic Access Persons with access to the Internet may obtain the documents at 
                    *http://www.fda.gov/​cdrh/​pmapage.html*. 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] BILLING CODE 4160-01-S