Notices. Notice
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/register/2005/07/15/05-13901A 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. 2005M-0024, 2005M-0025, 2005M-0026, 2005M-0092, 2005M-0087, 2005M-0055, 2005M-0089, 2005M-0027, 2005M-0109, 2005M-0028, 2005M-0088, 2005M-0110, 2005M-0132] 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 January 1, 2005, through March 31, 2005. 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 January 1, 2005, through March 31, 2005** PMA No./Docket No. Applicant TRADE NAME Approval Date P010058/2005M-0024 Medilink OSTEOSPACE March 15, 2004 P030029/2005M-0025 Bayer HealthCare, LLC ADVIA CENTAUR ANTI HBs READYPACK REAGENTS & ADVIA CENTAUR ANTI HBs READYPACK CALIBRATORS May 14, 2005 P030028/2005M-0026 Ophtec USA, Inc.; Ophtec BV ARTISAN (MODEL 206 & 204) PHAKIC INTRAOCULAR LENS
(PIOL)VERISYSE (VRSM5US & VRMA6US) PHAKIC INTRAOCULAR LENS September 10, 2004 P040006/2005M-0092 DePuy Spine, Inc. CHARITE ARTIFICIAL DISC October 26, 2004 P030007/2005M-0087 Eastman Kodak Co. KODAK MAMMAGRAPHY CAD ENGINE November 23, 2004 P930016 (S17)/2005M-0055 VISX, Inc. STAR S4 EXCIMER LASER SYSTEM WITH VARIABLE SPOT SCANNING
(VSS)& WAVESCAN WAVEFRONT SYSTEM December 14, 2004 P030030/2005M-0089 Genyx Medical URYX URETHRAL BULKING AGENT December 16, 2004 P030022/2005M-0027 Smith & Nephew, Inc. REFLECTION CERAMIC ACETABULAR SYSTEM December 17, 2004 P040004/2005M-0109 Bayer Healthcare LLC ADVIA CENTAUR HBC TOTAL READY PAK REAGENTS & ADVIA CENTAUR HBC TOTAL QUALITY CONTROL MATERIALS December 22, 2004 P030034/2005M-0028 Orthofix, Inc. CERVICAL-STIM MODEL 505L CERVICAL FUSION SYSTEM December 23, 2004 P040014/2005M-0088 Irvine Biomedical, Inc. IBI THERAPY CARDIAC ABLATION SYSTEM January 14, 2005 P040017/2005M-0110 Bayer Healthcare, LLC ADVIA CENTAUR ANTI-HAV TOTAL ASSAY & ADVIA CENTAUR TOTAL QUALITY CONTROL MATERIALS March 7, 2005 H030005/2005M-0132 CoAxia, Inc. COAXIA NEUROFLO CATHETER March 30, 2005 II. Electronic Access Persons with access to the Internet may obtain the documents at *http://www.fda.gov/cdrh/pmapage.html* . Dated: July 6, 2005. Linda S. Kahan, Deputy Director, Center for Devices and Radiological Health. [FR Doc. 05-13901 Filed 7-14-05; 8:45 am]
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