Proposed Rules. Notice
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/register/2001/07/06/01-16918A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
BILLING CODE 4160-01-C DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket Nos. 00M-1592, 01M-0072, 01M-0043, 00M-0014, 00M-0012, 00M-0011, 01M-0042, 00M-0055, 01M-0039, 00M-0015, 01M-0041, 00M-1683, 00M-0013, 00M-1684, 01M-0038, 01M-0062, 01M-0149, 01M-0201] 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 Dockets Management Branch. ADDRESSES: Submit written requests for copies of summaries of safety and effectiveness to the Dockets Management Branch (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 summary 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 to revise §§ 814.44(d) and 814.45(d) (21 CFR 814.44(d) and 814.45(d)) to discontinue publication of individual PMA approvals and denials in the **Federal Register** . Instead, revised §§ 814.44(d) and 814.45(d) state that FDA will notify the public of PMA approvals and denials by posting them on FDA’s Intranet home page at http://www.fda.gov; by placing the summaries of safety and effectiveness on the Internet and in FDA's Dockets Management Branch; and by publishing in the **Federal Register** after each quarter a list of available safety and effectiveness summaries of approved PMAs and denials announced in that quarter. 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 following is a list of approved PMAs for which summaries of safety and effectiveness were placed on the Internet in accordance with the procedure explained previously from January 1, 2001, through March 31, 2001. 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, 2001, through March 31, 2001** PMA No./Docket No. Applicant Trade Name Approval Date P970043/00M-1592 Autonomous Technologies Corp. LADARVision® Excimer Laser System November 2, 1998 P970025/01M-0072 DiaSorin, Inc. PRO-TRAC II TM Tacrolimus ELISA Kit April 27, 1999 P970049/01M-0043 Laser Institute of the Rockies Dishler Excimer Laser System December 16, 1999 P970053(S2)/00M-0014 Nidek Technologies, Inc. EC 5000 Excimer Laser System April 14, 2000 P990074/00M-0012 McGhan Medical Corp. RTV Saline-Filled Breast Implants May 10, 2000 P990075/00M-0011 Mentor Corp. Saline-Filled and Spectrum® Mammary Prostheses May 10, 2000 P000009/01M-0042 Biotronik, Inc. Phylax AV Implantable Cardioveter Defibrillator with Program Software September 29, 2000 P000011/00M-0055 Biocompatibilities Cardiovascular, Inc. Biodiv Ysio TM AS PC Coated Stent and Delivery System September 29, 2000 P000022/01M-0039 Medtronic AVE, Inc. AVE BeStent TM 2 with Discrete Technology TM Coronary Stent Delivery System October 16, 2000 P930016(S10)/00M-0015 VISX, Inc. STAR S2 and S3 Excimer Laser System October 18, 2000 P910023(S47)/01M-0041 St. Jude Medical, Inc. Photon TM DR Implantable Cardioverter Defibrillator
(ICD)October 27, 2000 P000027/00M-1683 Roche Diagnostics Corp. Elecsys Free Immunoassay Calset/Calcheck December 12, 2000 P970013/00M-0013 St. Jude Medical, Inc. Microny TM SR+ Model 2425T December 21, 2000 P980020/00M-1684 Q Care International, LLC Q 103 Needle Management Systems December 21, 2000 P950021(S2)/01M-0038 Bayer Corp. ACS: 180 and Advia Centaur PSA Assays December 22, 2000 H000001/01M-0062 JOMED AB JOMED JOSTENT® Coronary Stent Graft January 10, 2001 P990085/01M-0149 VISTAKON (Division of Johnson & Johnson Vision Care, Inc.) VISTAKON Soft Contact Lenses for Extended Wear February 16, 2001 H990013/01M-0201 Ortec International, Inc. Composite Cultured Skin
(CCS)February 21, 2001 II. Electronic Access Persons with access to the Internet may obtain the documents at http://www.fda.gov/cdrh/pmapage.html. Dated: June 21, 2001. Linda S. Kahan, Deputy Director for Regulations Policy, Center for Devices and Radiological Health. [FR Doc. 01-16918 Filed 7-5-01; 8:45 am]
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