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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 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 at on the Internet, 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. Start Printed Page 36010 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 October 1, 2001, through December 31, 2001. 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 October 1, 2001, through December 31, 2001

PMA No./Docket No.ApplicantTrade NameApproval Date
P990050/01M-0478Spectrascience, Inc.Optical Biopsy SystemNovember 14, 2000
P000020/01M-0460C.R. Bard, Inc.Stinger Ablation Catheter Templink Extension CableNovember 29, 2000
P990043/01M-0454Diasorin, Inc.DIASORIN ETI-EBK PLUS AssayFebruary 8, 2001
P990042/01M-0453Diasorin, Inc.DIASORIN ETI-AB-AUK PLUS AssayMarch 30, 2001
P990041/01M-0452Diasorin, Inc.DIASORIN ETI-AB-EBK PLUS AssayMarch 30, 2001
P990045/01M-0456Diasorin, Inc.DIASORIN ETI-AB-COREK PLUS AssayMarch 30, 2001
P990038/01M-0451Diasorin, Inc.DIASORIN ETI MAK-2 PLUS AssayMarch 30, 2001
P990044/01M-0455Diasorin, Inc.DIASORIN ETI-CORE IGMK PLUS AssayMarch 30, 2001
P000040/01M-0578Bei Medical Systems Co., Inc.HYDROTHERMABLATOR Endometrial Ablation SystemApril 20, 2001
P990012/01M-0507Roche Diagnostics Corp.Elecsys Hbsag Immunoassay, Elecsys Hbsag Confirmatory, and Precicontrol HbsagJune 1, 2001
P000053/01M-0579American Medical Systems, Inc.AMS SPHINCTER 800 Urinary Control SystemJune 14, 2001
P930027(S004)/01M-0535Diagnostic Products Corp.Immulite PSA, Immulite Third Generation PSA, Immulite 2000June 19, 2001
P880086(S083)/01M-0462St. Jude Medical, Inc.Integrity AFX DR Model 5346 Dual Chamber Pulse Generator and Programmer Software Model 3307, V2.2aJuly 11, 2001
P830045(S076)/01M-0461St. Jude Medical, Inc.Integrity AFX DR Model 5346 Dual Chamber PulseJuly 11, 2001
P010021/01M-0536Ortho-Clinical Diagnostics, Inc.Vitros Immunodiagnostic Products Anti-HCV Reagent Pack and CalibratorAugust 30, 2001
P890057(S014)/01M-0520Sensor Medics Corp.Model 3100b High Frequency Oscillatory Ventilator (HFOV)September 24, 2001
P000029/01M-0439Q-Med AbDeflux Injectable Gel RenSeptember 24, 2001
P010017/01M-0509Fisher Imaging Corp.SENOSCAN Full Field Digital Mammagraphy SystemSeptember 25, 2001
P980008(S005)/01M-0490Lasersight Technologies, Inc.Lasersight Laserscan Lsx Excimer Laser System For Laser-Assisted In Situ Keratomileusis (LASIK)September 28, 2001
P000036/01M-0498Advanced Tissue SciencesDermagraftSeptember 28, 2001
P010019/01M-0479Ciba Vision Corp.Focus Night And Day (Lotrafilcon A) Soft Contact LensesOctober 11, 2001
P000030/01M-0480Ciba Vision Corp.Focus Night & Day (Lotrafilcon A) Soft Contact LensesOctober 12, 2001
H010002/01M-0482Stryker BiotechOP-1 ImplantOctober 17, 2001
P000052/01M-0508Guidant Corp.Galileo Intravascular Radiotherapy SystemNovember 2, 2001
P930016(S014)/01M-0522VISX, Inc.VISX STAR Excimer Laser SystemNovember 6, 2001
P010007/01M-0537Diagnostic Products Corp.Immulite/Immulite 2000 Afp AssaysNovember 9, 2001
P990015/01M-0523Lifecore Biomedical, Inc.Intergel Adhesion Prevention SolutionNovember 16, 2001
P000057/01M-0530Ascension Orthopedics, Inc.Ascension McpNovember 19, 2001
P980006(S004)/01M-0531Bausch & Lomb, Inc.Purevision (Balafilcon A) Visibility Tinted Contact LensesNovember 20, 2001
P010032/01M-0534Advanced Neuromodulation System, Inc.Genesis Neurostimulation (Ipg) SystemNovember 21, 2001
P010003/01M-0567Cryolife, Inc.BIOGLUE Surgical AdhesiveDecember 3, 2001
P010020/01M-0581American Medical Systems, Inc.AMS Acticon NeosphincterDecember 18, 2001
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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: May 10, 2002.

Linda S. Kahan,

Deputy Director, Center for Devices and Radiological Health.

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[FR Doc. 02-12728 Filed 5-21-02; 8:45 am]