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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 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.

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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 January 30, 1998 (63 FR 4571), FDA 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 to FDA's home page at on the Internet. 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, 2003, through June 30, 2003. 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, 2003, through June 30, 2003

PMA No./Docket No.ApplicantTrade NameApproval Date
P010052/2003M-0287Diagnostic Products Corp.Immulite/Immulite 2000 Anti-HBSJuly 22, 2002
P010051/2003M-0271Diagnostic Products Corp.Immulite/Immulite 2000 Anti-HBCJuly 24, 2002
P010053/2003M-0272Diagnostic Products Corp.Immulite/Immulite 2000 Anti-HBC IGMJuly 26, 2002
P010050/2003M-0262Diagnostic Products Corp.Immulite/Immulite 2000 HBSAF and Immulite HBSAF Confirmatory KitJuly 26, 2002
P020014/2003M-0175Conceptus, Inc.Essure SystemNovember 4, 2002
P990069/2003M-0240EpMed Systems, Inc.Alert System (Alert Catheter, Alert Interface Cable, and Alert Companion With Software Version 1.08)November 27, 2002
P010055/2003M-0189Prostalund Operations ABProstalund Coretherm System Microwave Thermotherapy for BPHDecember 23, 2002
P020028/2003M-0241Philips Medical SystemSeries 50 XMO (Model M1350C) Fetal/Maternal Monitor System With Integrated Fetal Oxygen Saturation MonitoringJanuary 3, 2003
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P990027(S004)/2003M-0174Bausch & Lomb Surgical, Inc.Technolas 217A Excimer Laser SystemFebruary 25, 2003
P990086(S003)/2003M-0173Health Tronics Surgical Services, Inc.Healthtronics OssatronMarch 14, 2003
P980035(S013)/2003M-0190Medtronic, Inc.Medtronic AT500 DDDRP Pacing System (Model A1501) and Model 9968 SoftwareMarch 27, 2003
H020007/2003M-0157Medtronic NeurologicalMedtronic Activa Dystonia TherapyApril 15, 2003

II. Electronic Access

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

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Dated: October 20, 2003.

Linda S. Kahan,

Deputy Director, Center for Devices and Radiological Health.

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[FR Doc. 03-27882 Filed 11-5-03; 8:45 am]