[Federal Register Volume 65, Number 242 (Friday, December 15, 2000)]
[Notices]
[Pages 78495-78496]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-31960]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. 00M-1391, 00M-1536, 00M-1447, 00M-1522, 00M-0809, 00M-
1517, 00M-1451, 00M-1448, 00M-1507, 00M-1389, 00M-1388, 00M-1508, 00M-
1390, 00M-1386, 00M-1387, 00M-1414, 00M-1415, 00M-1416, 00M-1495, 00M-
1437, 00M-1475, 00M-1483, 00M-1515, 00M-1524, 00M-1523]


Medical Devices; Availability of Safety and Effectiveness 
Summaries for Premarket Approval Applications

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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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

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.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of January 30, 1998 (63 FR 4571), FDA 
published a final rule to revise Secs. 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 
Secs. 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 
Sec. 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.

[[Page 78496]]



            Table 1.--List of Safety and Effectiveness Summaries for Approved PMA's Made Available July 1, 2000, Through September 30, 2000
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       PMA Number/Docket No.                         Applicant                                Trade Name                          Approval Date
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P930016(S7)/00M-1391                 VISX, Inc.                                VISX STAR S2 Excimer Laser System         November 2, 1998
P920030(S2)/00M-1536                 Chiron Corp.                              CIBA Corning ACS PSA Immunoassay          December 8, 1998
P910065(S1)/00M-1523                 Tosoh Medics, Inc.                        AIA-PACK PA                               September 10, 1999
P990010/00M-1447                     CRS Clinical Research, Inc.               VISX Inc. Excimer Laser System Model C    November 19, 1999
                                                                                ``STAR''
P940035(S2)/00M-1522                 Matritech Inc.                            Matritech NMP22 Test Kit        January 18, 2000
P990023/00M-0809                     Alcon Laboratories                        Cellugel Ophthalmic             February 24, 2000
                                                                                Viscosurgical Device
P990054/00M-1517                     Cardiac Pathways Corp.                    Chilli Cooled Ablation System   March 17, 2000
H990014/00M-1451                     Medtronic Inc.                            EnterraTM Therapy System (formerly named  March 31, 2000
                                                                                Gastric Electrical Stimulation (GES)
                                                                                System)
P990053/00M-1448                     Nellcor Puritan Bennett                   OxiFirst Fetal Oxygen           May 12, 2000
                                                                                Saturation Monitoring System
P990028/00M-1507                     Focal, Inc.                               Focal Seal-L Synthetic Absorbable         May 26, 2000
                                                                                Sealant
P980050/00M-1389                     Medtronic Inc.                            Medtronic Jewel AF    June 14, 2000
                                                                                7250 Dual Chamber Implantable
                                                                                Cardioverter Defibrillator
P990025/00M-1388                     Biosense Webster, Inc.                    NAVI-STAR Diagnostic/Ablation             June 15, 2000
                                                                                Deflectable Tip Catheter
P950032(S16)/00M-1508                Organogenesis, Inc.                       Apligraf (Graftskin)                      June 20, 2000
P99037/00M-1390                      Vascular Solutions, Inc.                  Vascular Solutions Duett Sealing Device   June 22, 2000
P990078/00M-1386                     Sunrise Technologies                      Hyperion LTK System                       June 30, 2000
P990021/00M-1387                     QLT Photo Therapeutics, Inc.              Diomed 630 PDT Laser, Model T2USA         June 30, 2000
P990018/00M-1414                     Menicon USA, Inc.                         MeniconTM Z Rigid Gas Permeable Contact   July 11, 2000
                                                                                Lens
P000006/00M-1415                     Mentor Corp.                              Alpha 1 Inflatable Penile Prosthesis      July 14, 2000
P990064/00M-1416                     Medtronic Inc.                            Mosaic Porcine Bioprosthesic    July 14, 2000
                                                                                Heart Valve
P990034/00M-1495                     Medtronic Inc.                            Medtronic IsoMed      July 21, 2000
                                                                                Constant Flow Infusion System
P990039/00M-1437                     Metra Biosystems, Inc.                    QUS-2TM Calcaneal Ultrasonometer          August 1, 2000
P990072/00M-1475                     Westcon Contact Lens Co., Inc.            W-55 (Methafilcon A) and Horizon 55 Soft  August 22, 2000
                                                                                Extended Wear Contact Lenses
P860057(S11)/00M-1483                Edwards Lifesciences, LLC                 Carpentier-Edwards PERIMOUNT Pericardial  August 28, 2000
                                                                                Bioprosthesis
P970042/00M-1515                     Medstone International, Inc.              Medstone STSTM Lithotripter               September 5, 2000
P990055/00M-1524                     Bayer Corp.                               Bayer Immuno 1TM Complexed PSA Assay      September 8, 2000
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II. Electronic Access

    Persons with access to the Internet may obtain the documents at 
http://www.fda.gov/cdrh/pmapage.html.

    Dated: December 5, 2000.
Linda S. Kahan,
Deputy Director for Regulations Policy, Center for Devices and 
Radiological Health.
[FR Doc. 00-31960 Filed 12-14-00; 8:45 am]
BILLING CODE 4160-01-F