[Federal Register Volume 64, Number 119 (Tuesday, June 22, 1999)]
[Notices]
[Pages 33306-33308]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-15755]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket Nos. 98M-0855, 98M-0722, 98M-0835, 98M-0856, 98M-0857, 98M-
0897, 98M-0907, 98M-0972, 98M-0999, 99M-0034, 99M-0894, 99M-0237, 99M-
0793]


Medical Devices; Availability of Summaries of Safety and 
Effectiveness

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

ADDRESSES: Summaries of safety and effectiveness are available on the 
World Wide Web (WWW) at http://www.fda.gov/cdrh/pmapage.html. Copies of 
summaries of safety and effectiveness are also available by

[[Page 33307]]

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. 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 on the Internet (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 the PMA approvals 
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 all PMA applications for which summaries 
of safety and effectiveness were placed on the Internet in accordance 
with the procedure as explained previously through March 31, 1999. 
There were no denial actions during this period. The list provides the 
manufacturer's name, the generic name or the trade name, and the 
approval date.

    Table 1.--List of Approved PMA's From September 25, 1998 through
                            December 31, 1998
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PMA Number/Docket
       No.             Applicant         Trade Name       Approval Date
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P970026/98M-0722   Miriad Ultra       Sound Scan 2000   May 29, 1998
                    Sound, Inc.        Sound Scan
                                       Compact Sound
                                       Scan Clinical
                                       Bone Sonometer
P970034/98M-0855   Ophthalmic         Ophthalmic        September 25,
                    Innovations        Innovations       1998
                    International,     International
                    Inc.               Modified C-Loop
P980017/98M-0835   Possis Medical,    Perma-Seal        September 25,
                    Inc.               Dialysis Access   1998
                                       Graft Model
                                       2C20
P980018/98M-0857   DAKO A/S           DAKO Herceptest   September 25,
                                                         1998
P980025/98M-0856   Logicon RDA        Logicon Caries    September 25,
                                       Detector          1998
P960014/98M-0897   Global             Magellan-C        Ooctober 5, 1998
                    Therapeutics,      Percutaneous
                    Inc.               Transluminal
                                       Coronary
                                       Angioplasty
                                       (PTCA)
                                       Catheters Model
                                       C22020, C22520,
                                       C23020, &
                                       C23520
P980016/98M-0907   Medtronic, Inc.    Medtronic Gem Dr  October 9, 1998
                                       Model 7271 Dual
                                       Chamber
                                       Implantable
                                       Cardioverter
                                       Defibrillator
                                       System with
                                       Model 9960 (Gem
                                       Dr) Applicator
P980023/98M-0972   Biotronik, Inc     Phylax            October 27, 1998
                                       Implantable
                                       Cardioverter
                                       Defibrillator
                                       System
D970012/98M-0999   American Medical   AMS 700 Series    November 2, 1998
                    Systems, Inc.      Inflatable
                                       Penile
                                       Prosthesis
                                       Product Line;
                                       AMS700CX,
                                       AMS700CXM,
                                       AMS700CX
                                       Preconnect, AMS
                                       700 Ultrex and
                                       AMS 700 Ultrex
                                       Plus
P980024/99M-0034   Vysis, Inc.        Path VysionTM;    December 11,
                                       HER-2 DNA Probe   1998
                                       Kit
P960025/99M-0894   Acromed Corp.      Brantigen I/F     February 2, 1999
                                       Cage
                                       Used with
                                       VSP
                                       Spine Plates
                                       and Pedicle
                                       Screws
P980006/99M-0237   Bausch & Lomb      Pure VisionTM     February 5, 1999
                    Inc.               Balafilcon A
                                       Visibility
                                       Tinted Contact
                                       Lens
P980041/99M-0793   Beckman Coulter,   Access AFP        February 8, 1999
                    Inc.               Reagents on the
                                       Access
                                       Immunoassay
                                       Analyzer
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[[Page 33308]]

    Dated: June 9, 1999.
 Linda S. Kahan,
 Deputy Director for Regulations Policy, Center for Devices and 
Radiological Health.
[FR Doc. 99-15755 Filed 6-21-99; 8:45 am]
BILLING CODE 4160-01-F