Notices. Notice
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/register/2004/09/30/04-21873·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
BILLING CODE 4160-01-S 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] 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 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 Date P890064(S9)/2004M-0147 Digene Diagnostics, Inc. DIGENE HYBRID CAPTURE 2
(HC2)HIGH-RISK HPV DNA TEST March 31, 2003 P020006/2004M-0145 Enteric Medical Technologies, Inc. ENTERYX PROCEDURE KIT April 22, 2003 P970027/2004M-0207 Abbott Laboratories ABBOTT AXSYM ANTIBODY TO HCV February 5, 2004 P980007/2004M-0253 Abbott Laboratories AXSYM FREE PSA February 5, 2004 H020008/2004M-0165 Stryker Biotech OP-1 PUTTY April 7, 2004 P010014/2004M-0200 Biomet, Inc. OXFORD MENISCAL UNICOMPARTMENTAL KNEE SYSTEM April 21, 2004 P030032/2004M-0199 Genzyme Biosurgery HYLAFORM (HYLAN B GEL) April 22, 2004 P030017/2004M-0256 Advanced Bionics Corp. Precision Spinal Cord Stimulation
(SCS)System April 27, 2004 P030023/2004M-0248 Ophtec USA, Inc. OCULAID/STABLEYES CAPULAR TENSION RINGS April 27, 2004 P000054/2004M-0249 Wyeth Pharmaceuticals, Inc. INFUSE BONE GRAFT April 30, 2004 P030035/2004M-0250 St. Jude Medical ST. JUDE FRONTIER BIVENTRICULAR CARDIAC PACING SYSTEM May 13, 2004 P010062/2004M-0260 Euclid Systems Corp. EUCLID SYSTEMS ORTHOKERATOLOGY (OPRIFOCOM A) CONTACT LENS FOR OVERNIGHT WEAR June 7, 2004 P030045/2004M-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]
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