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Notice

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 (PMA's) that have been approved. This list is intended to inform the public of the availability of safety and effectiveness summaries of approved PMA's through the Internet and the agency's Dockets Management Branch.

ADDRESSES:

Submit a written request 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 summary 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 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 http://www.fda.gov 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 PMA's 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 PMA's for which summaries of safety and effectiveness were placed on the Internet in accordance with the procedure explained previously from July 1, 2000, through September 30, 2000. 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.

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Table 1.—List of Safety and Effectiveness Summaries for Approved PMA's Made Available July 1, 2000, Through September 30, 2000

PMA Number/Docket No.ApplicantTrade NameApproval Date
P930016(S7)/00M-1391VISX, Inc.VISX STAR S2 Excimer Laser SystemNovember 2, 1998
P920030(S2)/00M-1536Chiron Corp.CIBA Corning ACS PSA ImmunoassayDecember 8, 1998
P910065(S1)/00M-1523Tosoh Medics, Inc.AIA-PACK PASeptember 10, 1999
P990010/00M-1447CRS Clinical Research, Inc.VISX Inc. Excimer Laser System Model C “STAR”November 19, 1999
P940035(S2)/00M-1522Matritech Inc.Matritech NMP22® Test KitJanuary 18, 2000
P990023/00M-0809Alcon LaboratoriesCellugel® Ophthalmic Viscosurgical DeviceFebruary 24, 2000
P990054/00M-1517Cardiac Pathways Corp.Chilli® Cooled Ablation SystemMarch 17, 2000
H990014/00M-1451Medtronic Inc.EnterraTM Therapy System (formerly named Gastric Electrical Stimulation (GES) System)March 31, 2000
P990053/00M-1448Nellcor Puritan BennettOxiFirst® Fetal Oxygen Saturation Monitoring SystemMay 12, 2000
P990028/00M-1507Focal, Inc.Focal Seal-L Synthetic Absorbable SealantMay 26, 2000
P980050/00M-1389Medtronic Inc.Medtronic® Jewel® AF 7250 Dual Chamber Implantable Cardioverter DefibrillatorJune 14, 2000
P990025/00M-1388Biosense Webster, Inc.NAVI-STAR Diagnostic/Ablation Deflectable Tip CatheterJune 15, 2000
P950032(S16)/00M-1508Organogenesis, Inc.Apligraf (Graftskin)June 20, 2000
P99037/00M-1390Vascular Solutions, Inc.Vascular Solutions Duett Sealing DeviceJune 22, 2000
P990078/00M-1386Sunrise TechnologiesHyperion LTK SystemJune 30, 2000
P990021/00M-1387QLT Photo Therapeutics, Inc.Diomed 630 PDT Laser, Model T2USAJune 30, 2000
P990018/00M-1414Menicon USA, Inc.MeniconTM Z Rigid Gas Permeable Contact LensJuly 11, 2000
P000006/00M-1415Mentor Corp.Alpha 1 Inflatable Penile ProsthesisJuly 14, 2000
P990064/00M-1416Medtronic Inc.Mosaic® Porcine Bioprosthesic Heart ValveJuly 14, 2000
P990034/00M-1495Medtronic Inc.Medtronic® IsoMed® Constant Flow Infusion SystemJuly 21, 2000
P990039/00M-1437Metra Biosystems, Inc.QUS-2TM Calcaneal UltrasonometerAugust 1, 2000
P990072/00M-1475Westcon Contact Lens Co., Inc.W-55 (Methafilcon A) and Horizon 55 Soft Extended Wear Contact LensesAugust 22, 2000
P860057(S11)/00M-1483Edwards Lifesciences, LLCCarpentier-Edwards PERIMOUNT Pericardial BioprosthesisAugust 28, 2000
P970042/00M-1515Medstone International, Inc.Medstone STSTM LithotripterSeptember 5, 2000
P990055/00M-1524Bayer Corp.Bayer Immuno 1TM Complexed PSA AssaySeptember 8, 2000

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 5, 2000.

Linda S. Kahan,

Deputy Director for Regulations Policy, Center for Devices and Radiological Health.

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[FR Doc. 00-31960 Filed 12-14-00; 8:45 am]

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