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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 (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.


Summaries of safety and effectiveness are available on the Internet at​cdrh/​pmapage.html. Copies of summaries of safety and effectiveness are also available by submitting a written request 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 in the SUPPLEMENTARY INFORMATION section of this document when submitting a written request.

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Kathy M. Poneleit, 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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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 Internet home page 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 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)(3) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360e(d)(3)), 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 January 1, 2000, through March 31, 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.

Table 1.—List of Safety and Effectiveness Summaries for Approved PMA's Made Available January 1, 2000, through March 31, 2000

PMA Number/Docket No.ApplicantTrade NameApproval Date
P970005/00M-0811Kremer Laser Eye CenterKremer Exciber Laser System (Serial #KEA940202)July 30, 1998
P970055/00M-1215Biotrin International, Ltd.Biotrin Parvovirus IgM EIA (V619IMUS)August 6, 1999
P970054/00M-1216Biotrin International, Ltd.Biotrin Parvovirus IgG EIA (V519IGUS)August 6, 1999
P980049/00M-0915ELA Medical, Inc.Defender II Model 9201 Implantable Cardiovascular DefibrillatorSeptember 15, 1999
H990003/99M-4619American Medical SystemsActiconTM NeosphincterSeptember 20, 1999
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P850022(S9)/00M-0901Biolectron Inc.SpinalPak® StimulatorSeptember 24, 1999
H990005/99M-4763Nitinol Medical TechnologiesCardioSEAL® Septal Occlusion SystemSeptember 28, 1999
P930034(S12)/00M-0424Summit TechnologySVS Apex Plus Excimer Laser Workstation w/the Emphasis DiscsOctober 21, 1999
P910066(S11)/00M-1073Orthologic Corp.OrthologicTM 1000 Bone Growth StimulatorDecember 17, 1999
P990035/00M-0577Sunlight Ultrasound Technologies, Ltd.The SunlightTM Omnisense Ultrasound Bone SonometerJanuary 20, 2000
P990066/00M-0579GE Medical SystemsSenographe 2000DJanuary 28, 2000
H990011/00M-0599Nitinol Medical TechnologiesCardioSEAL® Septal Occlusion SystemFebruary 1, 2000
P980040/00M-0445Allergan Inc.Sensar Soft Acrylic UV-Light Absorbing Posterior Chamber Intraocular LensFebruary 3, 2000
P990016/00M-0580McCue Corporation, Inc.McCue CUBAClinical Ultraonic Bone Sonometry System w/CUBAplus+V4.1.0February 15, 2000
P940034(S8)/00M-0578Gen-Probe IncorporatedGen-Probe® AmplifiedTM Mycobacterium Tuberculosis Direct (MTD) TestFebruary 15, 2000
P900009(S6)/00M-0810Smith & Nephew Inc.Exogen 2000 or Sonic Accelerated Fracture Healing SystemFebruary 22, 2000
P990023/00M-0809Alcon LabsCellugel® Ophthalmic Viscosurgical DeviceFebruary 24, 2000
P950019(S9)/00M-1212United States Surgical Corp.Ray Threaded Fusion Cage (TFC) w/InstrumentationMarch 2, 2000
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Dated: May 23, 2000.

Linda S. Kahan,

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

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[FR Doc. 00-14702 Filed 6-9-00; 8:45 am]