This site displays a prototype of a “Web 2.0” version of the daily Federal Register. It is not an official legal edition of the Federal Register, and does not replace the official print version or the official electronic version on GPO’s govinfo.gov.
The documents posted on this site are XML renditions of published Federal Register documents. Each document posted on the site includes a link to the corresponding official PDF file on govinfo.gov. This prototype edition of the daily Federal Register on FederalRegister.gov will remain an unofficial informational resource until the Administrative Committee of the Federal Register (ACFR) issues a regulation granting it official legal status. For complete information about, and access to, our official publications and services, go to About the Federal Register on NARA's archives.gov.
The OFR/GPO partnership is committed to presenting accurate and reliable regulatory information on FederalRegister.gov with the objective of establishing the XML-based Federal Register as an ACFR-sanctioned publication in the future. While every effort has been made to ensure that the material on FederalRegister.gov is accurately displayed, consistent with the official SGML-based PDF version on govinfo.gov, those relying on it for legal research should verify their results against an official edition of the Federal Register. Until the ACFR grants it official status, the XML rendition of the daily Federal Register on FederalRegister.gov does not provide legal notice to the public or judicial notice to the courts.
Food and Drug Administration, HHS.
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.
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.Start Further Info
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.End Further Info End Preamble Start Supplemental Information
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 Start Printed Page 11987announcements 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 October 1, 2004, through December 31, 2004. 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.
|PMA No./Docket No.||Applicant||Trade Name||Approval Date|
|P020022/2004M-0538||Bayer Healthcare, LLC||BAYER VERSANT HCV RNA 3.0 ASSAY (bDNA)||March 28, 2003|
|P020021/2004M-0495||Wilson-Cook Medical, Inc./applicant at approval was Axcan Scandipharm, Inc.||WIZARD X-CELL PHOTODYNAMIC THERAPY BALLOON WITH FIBER OPTIC DIFFUSER||August 1, 2003|
|P040029/2004M-0450||Szabocsik & Associates||JSZ ORTHOKERATOLOGY (OPRIFOCON A) CONTACT LENSES FOR OVERNIGHT WEAR||September 29, 2004|
|P030032(S1)/2004M-0467||Genzyme Biosurgery||HYLAFORM PLUS (HYLAN B GEL)||October 13, 2004|
|P030011/2004M-0471||Syncardia Systems, Inc.||SYNCARDIA TEMPORARY CARDO WEST TOTAL ARTIFICAL HEART (TAH-t)||October 15, 2004|
|P040002/2004M-0533||Endologix, Inc.||ENDOLOGIX POWERLINK SYSTEM||October 29, 2004|
|P040022/2004M-0496||Medtronic, Inc./applicant at approval was AngioLink Corp.||EVS VASCULAR CLOSURE SYSTEM||November 3, 2004|
|P030031/2004M-0497||Biosense Webster, Inc.||BIOSENSE WEBSTER NAVISTAR/CELSIUS THERMO-COOL DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETERS||November 5, 2004|
II. Electronic Access
Persons with access to the Internet may obtain the documents at http://www.fda.gov/cdrh/pmapage.html.Start Signature
Dated: March 2, 2005.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. 05-4763 Filed 3-9-05; 8:45 am]
BILLING CODE 4160-01-S