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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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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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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 January 1998, FDA revised 21 CFR 814.44(d) and 814.45(d) (63 FR 4571, January 30, 1998) to discontinue individual publication of PMA approvals and denials in the Federal Register, providing instead to post this information to FDA's home page at Start Printed Page 67630 on the Internet. In addition, 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. 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 described above from April 1, 2002, through June 30, 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 April 1, 2002, Through June 30, 2002

PMA Number/Docket No.ApplicantTrade NameApproval Date
P000008/02M-0250BioEntrics Corp.LAP-BAND Adjustable Gastric Banding SystemJune 5, 2001.
P980033/02M-0203Boston Scientific Scimed, Inc.WALLSTENT EndoprosthesisNovember 16, 2001.
P010027/02M-0180Ophthalmic Innovations International, Inc.ALLERGAN, INC. Model AC 21B Anterior Chamber Intraocular Lens (Cataract)November 21, 2001.
P010033/02M-0218Cellestis Ltd.QUANTIFERON-TBNovember 28, 2001.
P000049/02M-0272Nitinol Medical Technologies, Inc.CARDIOSEAL Septal Occlusion System With QWIKLOADDecember 5, 2001.
P000039/02M-0271AGA Medical Corp.THE AMPLATZER Septal Occluder (ASO) And AMPLATZER Exchange SystemDecember 5, 2001.
P010030/02M-0145Lifecor, Inc.Wearable Cardioverter Defibrillator (WCD) 2000 “Lifevest” SystemDecember 18, 2001.
P980024(S1)/02M-0172VysisPATHVYSION HER-2 DNA Probe KitDecember 31, 2001.
P9600009(S7)/02M-0217Medtronic, Inc.MEDTRONIC ACTIVA Parkinson's Control SystemJanuary 14, 2002.
P010054/02M-0179Roche Diagnostics Co.ELECSYS ANTI-HBS Immunoassay PRECICONTROL ANTI02M-HBSFebruary 28, 2002.
P000037(S1)/02M-0255Medical Carbon Research Institute, LLCON-X Prosthetic Heart Valve, Models ONXM and ONXMCMarch 6, 2002.
P010025/02M-0173Hologic, Inc.LORAD Digital Breast ImagerMarch 15, 2002.
P000033/02M-0235SulzerIntra Therapeutics, Inc.INTRACOIL Self-Expanding Peripheral StentApril 3, 2002.
H000007/02M-0167AGA Medical Corp.AMPLATZER PFO OccluderApril 5, 2002.
P010018/02M-0174Refractec, Inc.VIEWPOINT CK SYSTEMApril 11, 2002.
P900033(S8)/02M-0216Integra Lifesciences, Corp.INTEGRA Dermal Regeneration TemplateApril 19, 2002.
P010012/02M-0236Guidant Corp.CONTAK CD/EASYTRAK Lead System, Models 4510, 4511, 4512, And 4513May 2, 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: October 23, 2002.

Linda S. Kahan,

Deputy Director, Center for Devices and Radiological Health.

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[FR Doc. 02-28155 Filed 11-5-02; 8:45 am]