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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 Radiological 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 Start Printed Page 75074notification 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 July 1, 2004, through September 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 July 1, 2004, through September 30, 2004

PMA No./Docket No.ApplicantTrade NameApproval Date
P020026/2003M-0172Cordis Corp.CYPHER SIROLIMUS-ELUTING CORONARY STENT ON THE RAPTOR OVER-THE-WIRE DELIVERY SYSTEM OR RAPTORRAIL RAPID EXCHANGE DELIVERY SYSTEMApril 24, 2003
P020023/2004M-0309Q-Med Scandinavia, Inc.RESTYLANE INJECTABLE GELDecember 12, 2003
P030044/2004M-0433DakoCytomation California, Inc.DAKOCYTOMATION EGFR PHARMDXFebruary 12, 2004
P030024/2004M-0341Ortho-Clinical Diagnostics, Inc.VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT PACK AND CALIBRATORMarch 4, 2004
P030026/2004M-0356Ortho-Clinical Diagnostics, Inc.VITROS IMMUNODIAGOSTIC PRODUCTS ANTI-HBC IGM REAGENT PACK AND CALIBRATORMarch 4, 2004
P030025/2004M-0403Boston Scientific Corp.TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM (MONORAIL AND OVER-THE-WIRE)March 4, 2004
P020030/2004M-0310Ela Medical, Inc.STELID II/STELIX/STELIX II ENDOCARDIAL PACING LEADJune 17, 2004
P970043 (S015)/2004M-0312Alcon Laboratories, Inc.LADARVISION 4000 EXCIMER LASER SYSTEMJune 29, 2004
P030054/2004M-0313St. Jude Medical, Inc.ST. JUDE MEDICAL EPIC HF SYSTEMJune 30, 2004
P040008/2004M-0342bioMerieux, Inc.VIDAS TPSA ASSAYJuly 8, 2004
P030012/2004M-0323R2 Technology, Inc.IMAGECHECKER CT CAD SOFTWARE SYSTEM (MODEL LN-1000)July 8, 2004
P010061/2004M-0345Photo Cure, ASACURELIGHT BROADBAND (MODEL CURELIGHT 01)July 28, 2004
P030050/2004M-0350Dermik LaboratoriesSCULPTRAAugust 3, 2004
P030010/2004M-0387Siemens Medical Solutions USA, Inc.SIEMENS MAMMOMAT NOVATIONDR FULL FIELD DIGITAL MAMMOGRAPHY SYSTEMAugust 20, 2004
H030009/2004M-0415Synthes (USA)VERTICAL EXPANDABLE PROSTHETIC TITANIUM RIB (VEPTR)August 24, 2004
P040012/2004M-0388Guidant Corp.ACULINK CAROTID STENT SYSTEM & RX ACCULINK CAROTID STENT SYSTEMAugust 30, 2004
P010012 (S026)/2004M-0430Guidant Corp.CONTAK CD (MODEL 1823), CONTAK CD 2 (MODELS H115 & H119), RENEWAL (MODEL H135), RENEWAL 3 (MODELS H170, H175, H177, & H179)September 14, 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: December 3, 2004.

Linda S. Kahan,

Deputy Director, Center for Devices and Radiological Health.

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[FR Doc. 04-27387 Filed 12-14-04; 8:45 am]

BILLING CODE 4160-01-S