[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
