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

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Information about this document as published in the Federal Register.

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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 Dockets Management Branch.


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 summaries of safety and effectiveness.

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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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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 home page on the Internet at, 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, 2002, through March 31, 2002. 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, 2002, through March 31, 2002

PMA Number/Docket No.ApplicantTrade NameApproval Date
P000012/02M-0083Roche Molecular Systems, Inc.COBAS AMPLICOR Hepatitis C Virus Test, version 2.0.July 3, 2001.
P000010/02M-0082Roche Molecular Systems, Inc.AMPLICOR Hepatitis C Virus Test, version 2.0.July 5, 2001.
P000025/02M-0006Med-El Corp.MED-EL COMBI 40+ Cochlear Implant System.August 20, 2001.
P010013/02M-0128Novacept, Inc.NOVASURE Impedance Controlled Endometrial Ablation System.September 28, 2001.
P010022/02M-0076Cohesion Technologies, Inc.COSEAL Surgical Sealant.December 14, 2001.
P000048/02M-0034Dornier Medical Systems, Inc.DORNIER EPOS ULTRA.January 15, 2002.
P010038/02M-0030Intelligent Systems Software, Inc.MAMMOREADER (Computer-Aided Detection System For Mammography).January 15, 2002.
P010034/02M-0060CADx Medical Systems, Inc.SECOND LOOK (Computer-Aided Detection System For Mammography).January 31, 2002.
P010040/02M-0118Safeguard Medical Devices, Inc.The DISINTEGRATOR Insulin Needle Destruction Device.March 15, 2002.
H010005/02M-0121Ascension Orthopedics, Inc.ASCENSION PIP.March 22, 2002.
P010049/02M-0134SUB-Q, Inc.QuickSeal Femoral Arterial Closure System.March 25, 2002.
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II. Electronic Access

Persons with access to the Internet may obtain the documents at​cdrh/​pmapage.html.

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Dated: July 5, 2002.

Linda S. Kahan,

Deputy Director, Center for Devices and Radiological Health.

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[FR Doc. 02-18038 Filed 7-16-02; 8:45 am]