[Printable PDF]
[Federal Register: March 31, 2000 (Volume 65, Number 63)]
[Notices]
[Page 17285-17286]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr31mr00-68]
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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)),
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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