[Federal Register Volume 65, Number 63 (Friday, March 31, 2000)]
[Notices]
[Pages 17285-17286]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-7935]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. 00M-1031 and 00M-1032]


Medical Devices Regulated by the Center for Biologics Evaluation 
and Research; List of Premarket Approval Actions

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 
Internet at http://www.fda.gov/cber/appr1999/1999approv.htm. 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: Nathaniel L. Geary, Center for 
Biologics Evaluation and Research (CBER) (HFM-17), Food and Drug 
Administration, 1401 Rockville Pike, Rockville, MD 20852-1448, 301-827-
6210.

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 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 the PMA approvals 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)),

[[Page 17286]]

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 the PMA applications reviewed within 
CBER, for which summaries of safety and effectiveness were placed on 
the Internet in accordance with the procedure as explained previously 
through September 30, 1999. There were no denial actions during this 
period. The list is in order by PMA number and provides the 
manufacturer's name, the generic name or trade name, and the approval 
date.

  Table 1.--List of Approval PMA's From July 2, 1999, Through September
                                30, 1999
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PMA Number/Docket
       No.             Applicant         Trade Name       Approval Date
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BP 97-0001/01/00M- Nexell             Isolex 300        July 2, 1999
 1031               Therapeutics,      Magnetic Cell
                    Inc.               Selection
                                       System and
                                       Isolex 300i
                                       Magnetic Cell
                                       Selection
                                       System
BP 97-0003/00M-    Dendreon Corp.     DACSTMSC          July 23, 1999
 1032
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    Dated: March 23, 2000.
Margaret M. Dotzel,
Acting Associate Commissioner for Policy.
[FR Doc. 00-7935 Filed 3-30-00; 8:45 am]
BILLING CODE 4160-01-F