[Federal Register Volume 65, Number 113 (Monday, June 12, 2000)]
[Notices]
[Pages 36817-36818]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-14702]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. 00M-0811, 00M-1215, 00M-1216, 00M-0915, 99M-4619, 00M-
0901, 99M-4763, 00M-0424, 00M-1073, 00M-0577, 00M-0579, 00M-0599, 00M-
0445, 00M-0580, 00M-0578, 00M-0810, 00M-0809, 00M-1212]


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: Summaries of safety and effectiveness are available on the 
Internet at http://www.fda.gov/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.

FOR FURTHER INFORMATION CONTACT: Kathy M. Poneleit, Center for Devices 
and Radiological Health (HFZ-402), Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850, 301-594-2186.

SUPPLEMENTARY INFORMATION: 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 
Internet home page at http://www.fda.gov; 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 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 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
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       PMA Number/Docket No.                     Applicant                                Trade Name                             Approval Date
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P970005/00M-0811                    Kremer Laser Eye Center             Kremer Exciber Laser System (Serial            July 30, 1998
                                                                         #KEA940202)
P970055/00M-1215                    Biotrin International, Ltd.         Biotrin Parvovirus IgM EIA (V619IMUS)          August 6, 1999
P970054/00M-1216                    Biotrin International, Ltd.         Biotrin Parvovirus IgG EIA (V519IGUS)          August 6, 1999
P980049/00M-0915                    ELA Medical, Inc.                   Defender II Model 9201 Implantable             September 15, 1999
                                                                         Cardiovascular Defibrillator
H990003/99M-4619                    American Medical Systems            ActiconTM Neosphincter                         September 20, 1999

[[Page 36818]]

 
P850022(S9)/00M-0901                Biolectron Inc.                     SpinalPak Stimulator                 September 24, 1999
H990005/99M-4763                    Nitinol Medical Technologies        CardioSEAL Septal Occlusion System   September 28, 1999
P930034(S12)/00M-0424               Summit Technology                   SVS Apex Plus Excimer Laser Workstation w/the  October 21, 1999
                                                                         Emphasis Discs
P910066(S11)/00M-1073               Orthologic Corp.                    OrthologicTM 1000 Bone Growth Stimulator       December 17, 1999
P990035/00M-0577                    Sunlight Ultrasound Technologies,   The SunlightTM Omnisense Ultrasound Bone       January 20, 2000
                                     Ltd.                                Sonometer
P990066/00M-0579                    GE Medical Systems                  Senographe 2000D                               January 28, 2000
H990011/00M-0599                    Nitinol Medical Technologies        CardioSEAL Septal Occlusion System   February 1, 2000
P980040/00M-0445                    Allergan Inc.                       Sensar Soft Acrylic UV-Light Absorbing         February 3, 2000
                                                                         Posterior Chamber Intraocular Lens
P990016/00M-0580                    McCue Corporation, Inc.             McCue CUBAClinical Ultraonic Bone Sonometry    February 15, 2000
                                                                         System w/CUBAplus+V4.1.0
P940034(S8)/00M-0578                Gen-Probe Incorporated              Gen-Probe AmplifiedTM Mycobacterium  February 15, 2000
                                                                         Tuberculosis Direct (MTD) Test
P900009(S6)/00M-0810                Smith & Nephew Inc.                 Exogen 2000 or Sonic Accelerated Fracture      February 22, 2000
                                                                         Healing System
P990023/00M-0809                    Alcon Labs                          Cellugel Ophthalmic Viscosurgical    February 24, 2000
                                                                         Device
P950019(S9)/00M-1212                United States Surgical Corp.        Ray Threaded Fusion Cage (TFC) w/              March 2, 2000
                                                                         Instrumentation
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    Dated: May 23, 2000.
Linda S. Kahan,
Deputy Director for Regulations Policy, Center for Devices and 
Radiological Health.
[FR Doc. 00-14702 Filed 6-9-00; 8:45 am]
BILLING CODE 4160-01-F