Notices. Notice
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/register/2004/05/07/04-10450A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
BILLING CODE 4120-03-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket Nos. 2003M-0337, 2003M-0332, 2003M-0343, 2003M-0242, 2003M-0333, 2003M-0339, 2003M-0320, 2003M-0356, 2003M-0305, 2003M-0352, 2003M-0381, 2003M-0375, 2003M-0427] 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 July 1, 2003, through September 30, 2003. 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 July 1, 2003, Through September 30, 2003** PMA No./Docket No. Applicant Trade Name Approval Date P000013/2003M-0337 Howmedica Ostenonics Corp. OSTEONICS ABC SYSTEM & TRIDENT SYSTEM HIP PROSTHESIS February 3, 2003 P010001/2003M-0332 Ceramtec AgWright Medical Technology CERAMIC TRANSCEND HIP ARTICULATION SYSTEM February 3, 2003 P020052/2003M-0343 St. Jude Medical, Daig Division, Inc. RESPONSE CV CATHETER SYSTEM May 7, 2003 P020018/2003M-0242 Cook, Inc. ZENITH AAA ENDOVASCULAR GRAFT AND H&L-B ONE-SHOT INTRODUCTION SYSTEM May 23, 2003 P930016(S16)/2003M-0333 Visx, Inc. STAR S4 ACTIVE TRAK EXCIMER LASER SYSTEM AND WAVE SCAN WAVE FRONT SYSTEM May 23, 2003 P020002/2003M-0339 Cytyc Corp. THINPREP IMAGING SYSTEM June 6, 2003 P020037/2003M-0320 X Technologies FX MINIRAIL RX PTCA CATHETER June 11, 2003 P030027/2003M-0356 Wright Cremascoli Ortho, SA CERAMIC TRANSCEND HIP ARTICULATION SYSTEM July 7, 2003 H020004/2003M-0305 Smith & Nephew Wound Management DERMAGRAFT July 7, 2003 P020049/2003M-0352 Hancock/Jaffe Laboratories PROCOL VASCULAR BIOPROSTHESIS July 29, 2003 P020036/2003M-0381 Cordis Corp. SMART AND SMART CONTROL NITINOL STENT SYSTEM August 12, 2003 P020033/2003M-0375 Independence Technology, LLC INDEPENDENCE IBOT 3000 MOBILITY SYSTEM August 13, 2003 P020025/2003M-0427 Boston Scientific EP TECHNOLOGIES EPT 1000 XP RF ABLATION SYSTEM August 25, 2003 II. Electronic Access Persons with access to the Internet may obtain the documents at *http://www.fda.gov/cdrh/pmapage.html* . Dated: April 26, 2004. Linda S. Kahan, Deputy Director, Center for Devices and Radiological Health. [FR Doc. 04-10450 Filed 5-6-04; 8:45 am]
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