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Medical Devices; Availability of Safety and Effectiveness Summaries for PMA

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Information about this document as published in the Federal Register.

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Food and Drug Administration, HHS.




The Food and Drug Administration (FDA) is publishing a list of premarket application (PMA) approvals. 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 home page on the Internet 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 October 1, 1999, through December 31, 1999. 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. Start Printed Page 16922

Table 1.—List of Safety and Effectiveness Summaries for Approved PMA's Made Available October 1, 1999, Through December 31, 1999

PMA Number/Docket No.ApplicantTrade NameApproval Date
P970010/99M-4361Synthes (USA)Norian Skeletal Repair System (SRS) Cancellous Bone CementDecember 23, 1998
P970015/99M-4277Sofamor DanekInter Fix Threaded Fusion DeviceMay 14, 1999
P960033/99M-4693Staar SurgicalStaarviscTM Sodium HyaluronateJuly 2, 1999
P980053/99M-4278Advanced Uroscience, Inc.Durasphere Injectable Bulking AgentSeptember 13, 1999
P990008/99M-4276Cook, Inc.Cook MBC PTCA Balloon Dilatation CatheterSeptember 27, 1999
P990001/99M-4281Vitatron, Inc.Diva Platform Implantable Pulse Generators & Pro Vit Application Software Version 3.3.2September 27, 1999
P990020/99M-4331Medtronic AneurxAneurx Stent Graft SystemSeptember 28, 1999
P980043/99M-4279Medtronic, Inc.Hancock II Bioprosthetic Heart ValveSeptember 28, 1999
P990017/99M-4280Guidant Cardiac & Vascular SurgeryEVT Abdominal Aortic Tube/EVT Abdominal Aortic Bifurcated EGS SystemSeptember 28, 1999
P990004/99M-4776Ethicon, Inc.Surgifoam Absorbable Gelatin Sponge, USPSeptember 30, 1999
P940034 (S008)/99M-4782Gen-Probe, Inc.Gen-Probe® Amplified Mycobacterium Tuberculosis Direct Test (MTD Test)September 30, 1999
P990002/99M-4330Rochester Medical Corp.Femsoft Urethral InsertSeptember 30, 1999
H980007/99M-4810Shelhigh, Inc.Shelhigh Pulmonic Valve Conduit Model NR-4000 with “No-React®” TreatmentSeptember 30, 1999
P990033/99M-4692Ceramed Corp.PepGen P-15October 25, 1999
P990014/99M-5135Bausch & Lomb Surgical, Inc.Hydroview Composite Hydrogel Foldable UV-Absorbing Posterior Chamber Intraocular LensNovember 12, 1999
H990007/99M-5327CryoLife, Inc.BioGlue® Surgical AdhesiveDecember 7, 1999
H980006/99M-5539MDS Nordion, Inc.TheraSphere®December 10, 1999
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Dated: March 14, 2000.

Linda S. Kahan,

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

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[FR Doc. 00-7780 Filed 3-29-00; 8:45 am]