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

Thu, 06/24/2010 - 6:32am
U.S. Food & Drug Administration

[Federal Register: June 24, 2010 (Volume 75, Number 121)] [Notices] [Page 36099-36100] From the Federal Register Online via GPO Access [wais.access.gpo.gov] [DOCID:fr24jn10-52] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket Nos. FDA-2009-M-0317, FDA-2009-M-0369, FDA-2009-M-0370, FDA- 2009-M-0485, FDA-2009-M-0536, FDA-2009-M-0540] 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 data 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: Nicole Wolanski, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 1650, Silver Spring, MD 20993, 301-796- 6570. 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 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 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, 2009, through September 30, 2009, and from October 1, 2009, through December 31, 2009. There were no denial actions during either 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, 2009, through December 31, 2009. ------------------------------------------------------------------------ PMA No. Docket Approval No. Applicant Trade Name Date ------------------------------------------------------------------------ P070022 Hologic, Inc. ADIANA PERMANENT July 6, FDA-2009-M-0317 CONTRACEPTION SYSTEM 2009 ------------------------------------------------------------------------ P060008/S11 Boston TAXUS LIBERTE LONG July 13, FDA-2009-M-0369 Scientific PACLITAXEL ELUING STENT 2009 Corp. SYSTEM ------------------------------------------------------------------------ P030050/S2 Sanofi SCULPTRA AESTHETIC July 28, FDA-2009-M-0370 Aventis, LLC 2009 ------------------------------------------------------------------------ P080013 Confluent DURASEAL XACT SEALANT September FDA-2009-M-0485 Surgical, SYSTEM 4, 2009 Inc. ------------------------------------------------------------------------ P080008 bioMerieux, VIDAS FREE PSA RT (fPSA) October 8, FDA-2009-M-0536 Inc. ASSAY 2009 ------------------------------------------------------------------------ P030042 Wright Medical CONSERVE PLUS TOTAL November FDA-2009-M-0540 Technology, RESURFACING HIP SYSTEM 3, 2009 Inc. ------------------------------------------------------------------------ II. Electronic Access Persons with access to the Internet may obtain the documents at http://www.fda.gov/cdrh/pmapage.html. Dated: June 17, 2010. Nancy Stade, Acting Associate Director for Regulations and Policy, Center for Devices and Radiological Health. [FR Doc. 2010-15259 Filed 6-23-10; 8:45 am] BILLING CODE 4160-01-S

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