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 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, 2004, through March 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.Start Printed Page 35655
|PMA No./Docket No.||Applicant||Trade Name||Approval Date|
|P970020(S40)/2004M-0024||Guidant Corp.||ACS MULTI-LINK RX/OTW DUET CORONARY STENT SYSTEMS||August 6, 2002|
|P890064(S9)/2004M-0147||Digene Corp.||DIGENE HYBRID CAPTURE 2 (HC2) HIGH-RISK HPV DNA TEST||March 31, 2003|
|P020006/2004M-0145||Enteric Medical Technologies, Inc.||ENTERYX PROCEDURE KIT||April 22, 2003|
|P020031/2004M-0031||Microsulis Corp.||MICROSULIS MICROWAVE ENDOMETRIAL ABLATION||September 23, 2003|
|P010059/2004M-0022||Morcher GMBH||MORCHER CAPSULAR TENSION RING, TYPES 14, 14A, and 14C||October 23, 2003|
|P030002/2004M-0012||Eyeonics, Inc.||CRYSTALENS MODEL AT-45 ACCOMMODATING POSTERIOR CHAMBER INTRAOCULAR LENS||November 14, 2003|
|P030005/2004M-0064||Guidant Corp.||CONTAK RENEWAL MODELS H125 and H120 WITH MODEL 2865 VERSION 1.8 APPLICATION SOFTWARE||January 26, 2004|
|P030006/2004M-0116||Celsion Corp.||PROLIEVE THERMODILATION SYSTEM||February 19, 2004|
|H030004/2004M-0084||Menssana Research, Inc.||HEARTSBREATH||February 24, 2004|
|H030003/2004M-0090||MicroMed Technology, Inc.||DEBAKEY VAD CHILD LEFT VENTRICULAR ASSIST SYSTEM||February 25, 2004|
|P010018(S5)/2004M-0134||Refractec, Inc.||VIEWPOINT CK SYSTEM||March 16, 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: June 7, 2004.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. 04-14439 Filed 6-24-04; 8:45 am]
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