[Federal Register Volume 65, Number 173 (Wednesday, September 6, 2000)]
[Notices]
[Pages 54057-54058]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-22700]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. 00M-1215, 00M-1216, 00M-1228, 00M-1229, 00M-1230, 00M-
1231, 00M-1298, 00M-1299, 00M-1300, 00M-1354]


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 applications (PMA) 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: Thinh X. Nguyen, 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 the 
Internet on FDA's 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

[[Page 54058]]

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 April 1, 2000, through June 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.

               Table 1.--List of Safety and Effectiveness Summaries for Approved PMA's Made Available April 1, 2000, through June 30, 2000
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   PMA Number/Docket No.                   Applicant                                  Trade Name                               Approval Date
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P970054/00M-1216             Hogan & Hartson                        Biotrin Parvovirus B19 IGG EIA (V5191GUS).     August 6, 1999
P970055/00M-1215             Hogan & Hartson                        Biotrin Parvovirus IGM EIA (V619IMUS).         August 6, 1999
P980008/00M-1231             Lasersight Technologies, Inc.          Laserscan LSX Excimer Laser System.            November 12, 1999
P990009/00M-1229             Fusion Medical Technologies, Inc.      Floseal Matrix/Floseal Matrix Hemostatic       December 8, 1999
                                                                     Sealant.
H990008/00M-1228             Interpore Cross International.         Telescopic Plate Spacer (TPS) Spinal System.   March 9, 2000
P990013/00M-1230             Starr Surgical Co.                     Collamer Single-Piece (Plate-Haptic)           April 2, 2000
                                                                     Ultraviolet Absorbing Posterior Chamber
                                                                     Intraocular Lens.
P990048/00M-1300             Hogan & Hartson                        Zeiss Visulas 690 and Visulink PD T/900 Laser  April 12, 2000
                                                                     System.
P990049/00M-1299             Coherent Medical Group                 Coherent Opal Photoactivator Laser System.     April 12, 2000
P950020/00M-1298             Interventional Technologies.           (BSDB) PTCA Surgical Dilation Balloon.         April 18, 2000
H99012/00M-1354              Cardiovascular Diagnostics, Inc.       TAS Ecarin Clotting Time Test.                 May 11, 2000
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    Dated: August 10, 2000.
Linda S. Kahan,
Deputy Director for Regulations Policy, Center for Devices and 
Radiological Health.
[FR Doc. 00-22700 Filed 9-5-00; 8:45 am]
BILLING CODE 4160-01-F