[Federal Register: October 28, 2003 (Volume 68, Number 208)] [Notices] [Page 61447-61448] From the Federal Register Online via GPO Access [wais.access.gpo.gov] [DOCID:fr28oc03-64] [[Page 61447]] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket Nos. 2003M-0045, 2003M-0122, 2003M-0010, 2003M-0040, 2003M- 0086, 2003M-0116, 2003M-0049, 2003M-0070, 2003M-0011, 2003M-0046, 2003M-0114, 2003M-0115] 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 revised 21 CFR 814.44(d) and 814.45(d) (63 FR 4571) to discontinue individual publication of PMA approvals and denials in the Federal Register. Instead, the agency now posts this information to FDA's home page at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov on the Internet. 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 January 1, 2003, through March 31, 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 January 1, 2003, through March 31, 2003 ------------------------------------------------------------------------ PMA No./ Docket No. Applicant Trade Name Approval Date ------------------------------------------------------------------------ P990071/ Biosense STOCKERT 70 RF GENERATOR May 31, 2000 03M-0045 Webster, FOR CARDIAC ABLATION Inc. P980048/ Sulzer Spine- BAK/CERVICAL (BAK/C) April 20, 2001 03M-0122 Tech INTERBODY FUSION SYSTEM P990065/ Sirtex SIR-SPHERES March 5, 2002 03M-0010 Medical, Inc. P010002/ United INDERMIL TISSUE ADHESIVE May 22, 2002 03M-0040 States Surgical Corp. P010041/ Edwards CARPENTIER-EDWARDS June 24, 2002 03M-0086 Lifescience S.A.V. BIOPROSTHESIS, s, LLC MODEL 2650 (AORTIC) P020009/ Boston EXPRESS/EXPRESS 2 September 11, 2002 03M-0116 Scientific, MONOTRAIL AND OVER THE Scimed, WIRE CORONARY STENT Inc. SYSTEMS P010068/ Biosense NAVISTAR DS/CELSIUS DS September 27, 2002 03M-0049 Webster, DIAGNOSTIC ABLATION Inc. CATHETERS, STOCKERT 70 GENERATOR, AND CATHETER INTERFACE CABLES P020011/ Gen-Probe, VERSANT HCV RNA November 7, 2002 03M-0070 Inc. QUALITATIVE ASSAY P020008/ Karl Storz KARL STORZ December 12, 2002 03M-0011 Endoscopy- AUTOFLUORESCENCE SYSTEM America P020027/ Dade DIMENSION FPSA FLEX January 24, 2003 03M-0046 Behring, REAGENT CARTRIDGE AND Inc. DIMENSION T/F PSA CALIBRATOR FOR DIMENSION RXL AND XPAND SYSTEMS P800022(S5 Inamed Corp. COSMODERM 1 & COSMOPLAST March 11, 2003 0)/03M- HUMAN-BASED COLLAGEN 0114 P010065/ E Med Future NEEDLE ZAP March 14, 2003 03M-0115 ------------------------------------------------------------------------ [[Page 61448]] II. Electronic Access Persons with access to the Internet may obtain the documents at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cdrh/pmapage.html. Dated: October 6, 2003. Linda S. Kahan, Deputy Director, Center for Devices and Radiological Health. [FR Doc. 03-27119 Filed 10-27-03; 8:45 am] BILLING CODE 4160-01-S