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Notice

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

Document Details

Information about this document as published in the Federal Register.

Published Document

This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format.

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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.

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FOR FURTHER INFORMATION CONTACT:

Thinh Nguyen, Center for Devices and Start Printed Page 58447Radiological Health (HFZ-402), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-2186.

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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 § 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 April 1, 2004, through June 30, 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.

Table 1.—List of Safety and Effectiveness Summaries for Approved PMAs Made Available From April 1, 2004 through June 30, 2004.

PMA No./Docket No.ApplicantTrade NameApproval Date
P890064(S9)/2004M-0147Digene Diagnostics, Inc.DIGENE HYBRID CAPTURE 2 (HC2) HIGH-RISK HPV DNA TESTMarch 31, 2003
P020006/2004M-0145Enteric Medical Technologies, Inc.ENTERYX PROCEDURE KITApril 22, 2003
P970027/2004M-0207Abbott LaboratoriesABBOTT AXSYM ANTIBODY TO HCVFebruary 5, 2004
P980007/2004M-0253Abbott LaboratoriesAXSYM FREE PSAFebruary 5, 2004
H020008/2004M-0165Stryker BiotechOP-1 PUTTYApril 7, 2004
P010014/2004M-0200Biomet, Inc.OXFORD MENISCAL UNICOMPARTMENTAL KNEE SYSTEMApril 21, 2004
P030032/2004M-0199Genzyme BiosurgeryHYLAFORM (HYLAN B GEL)April 22, 2004
P030017/2004M-0256Advanced Bionics Corp.Precision Spinal Cord Stimulation (SCS) SystemApril 27, 2004
P030023/2004M-0248Ophtec USA, Inc.OCULAID/STABLEYES CAPULAR TENSION RINGSApril 27, 2004
P000054/2004M-0249Wyeth Pharmaceuticals, Inc.INFUSE BONE GRAFTApril 30, 2004
P030035/2004M-0250St. Jude MedicalST. JUDE FRONTIER BIVENTRICULAR CARDIAC PACING SYSTEMMay 13, 2004
P010062/2004M-0260Euclid Systems Corp.EUCLID SYSTEMS ORTHOKERATOLOGY (OPRIFOCOM A) CONTACT LENS FOR OVERNIGHT WEARJune 7, 2004
P030045/2004M-0259Ev3 Inc.INTRASTENT DOUBLESTRUT STENTJune 8, 2004
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II. Electronic Access

Persons with access to the Internet may obtain the documents at http://www.fda.gov/​cdrh/​pmapage.html.

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Dated: September 23, 2004.

Linda S. Kahan,

Deputy Director, Center for Devices and Radiological Health.

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[FR Doc. 04-21873 Filed 9-29-04; 8:45 am]

BILLING CODE 4160-01-S